<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03297216</url>
  </required_header>
  <id_info>
    <org_study_id>17-1173</org_study_id>
    <secondary_id>1R01HD087119</secondary_id>
    <nct_id>NCT03297216</nct_id>
  </id_info>
  <brief_title>Improving Pregnancy Outcomes With Progesterone</brief_title>
  <acronym>IPOP</acronym>
  <official_title>Z 31702 - Improving Pregnancy Outcomes With Progesterone (IPOP): a Trial of 17-Hydroxyprogesterone Caproate to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>AMAG Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking&#xD;
      place in Zambia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Weekly intramuscular injections of 250mg 17-alpha hydroxyprogesterone caproate (17P) or&#xD;
      indistinguishable placebo will be randomly allocated in a 1:1 ratio started between 16-24&#xD;
      weeks gestation and administered weekly thereafter until 36 6/7 gestational weeks,&#xD;
      stillbirth, or delivery, whichever is sooner.&#xD;
&#xD;
      Individual participants will be followed from enrollment (prior to 24 weeks gestation)&#xD;
      through 42 days postpartum.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2018</start_date>
  <completion_date type="Actual">August 6, 2020</completion_date>
  <primary_completion_date type="Actual">June 25, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Phase III, double-masked, placebo-controlled, randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Experiencing Preterm Births or Stillbirths</measure>
    <time_frame>At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths</time_frame>
    <description>A composite of live births prior to 37 weeks of gestation or stillbirth occurring at any gestational age</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Preterm Birth &lt;37 Weeks</measure>
    <time_frame>At delivery, up to 37 weeks of gestation</time_frame>
    <description>Delivery prior to 37 gestational weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Preterm Birth &lt;34 Weeks</measure>
    <time_frame>At delivery, up to 34 weeks of gestation</time_frame>
    <description>Delivery prior to 34 gestational weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Preterm Birth &lt;28 Weeks</measure>
    <time_frame>At delivery, up to 28 weeks of gestation</time_frame>
    <description>Delivery prior to 28 gestational weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Stillbirth</measure>
    <time_frame>At delivery, up to approximately 40 weeks of gestation</time_frame>
    <description>Participants who had a fetus born without signs of life at any gestational age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Spontaneous Delivery &lt;37 Weeks</measure>
    <time_frame>At delivery, up to 37 weeks of gestation</time_frame>
    <description>Delivery prior to 37 weeks of gestation that was initiated spontaneously, without provider intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Spontaneous Delivery &lt;34 Weeks</measure>
    <time_frame>At delivery, up to 34 weeks of gestation</time_frame>
    <description>Delivery prior to 34 weeks of gestation that was initiated spontaneously, without provider intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Spontaneous Delivery &lt;28 Weeks</measure>
    <time_frame>At delivery, up to 28 weeks of gestation</time_frame>
    <description>Delivery prior to 28 weeks of gestation that was initiated spontaneously, without provider intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Infants With Birth Weight &lt;10th Percentile for Gestational Age</measure>
    <time_frame>Birth</time_frame>
    <description>Infant born with a weight below the 10th percentile for gestational age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Infants With Birth Weight &lt;3rd Percentile for Gestational Age</measure>
    <time_frame>Birth</time_frame>
    <description>Infant born with a weight below the 3rd percentile for gestational age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Infants Who Experienced Maternal-to-Child HIV Transmission</measure>
    <time_frame>At 6 weeks of life</time_frame>
    <description>Confirmed HIV infection in an infant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Neonatal Deaths</measure>
    <time_frame>Birth through 28 days postpartum</time_frame>
    <description>Death of an infant following live birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Infants With 1-minute Apgar Score &lt;7</measure>
    <time_frame>1 minute of life</time_frame>
    <description>Apgar score of less than 7 at 1 minute of life. Apgar stands for &quot;Appearance, Pulse, Grimace, Activity, and Respiration&quot; and is a quick test rated on a scale of 1-10 performed on a baby at one minute of life to determine how well the baby tolerated the birth process. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Infants With 5-minute Apgar Score &lt;7</measure>
    <time_frame>5 minutes of life</time_frame>
    <description>Apgar score of less than 7 at 5 minutes of life. Apgar stands for &quot;Appearance, Pulse, Grimace, Activity, and Respiration&quot; and is a quick test rated on a scale of 1-10 performed on a baby at five minutes of life to assess how well the baby is doing following delivery. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">800</enrollment>
  <condition>Pre-term Birth</condition>
  <condition>HIV-1-infection</condition>
  <arm_group>
    <arm_group_label>250 mg 17P</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>weekly intramuscular injection of 250mg 17P</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>weekly intramuscular injection of indistinguishable placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>17P</intervention_name>
    <description>Synthetic progestin</description>
    <arm_group_label>250 mg 17P</arm_group_label>
    <other_name>17-alpha hydroxyprogesterone caproate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Non-active placebo comparator</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  less than 24 0/7 weeks of gestation&#xD;
&#xD;
          -  viable intrauterine singleton pregnancy confirmed by ultrasound&#xD;
&#xD;
          -  antibody-confirmed HIV-1 infection&#xD;
&#xD;
          -  currently receiving antiretroviral l therapy (ART) or intending to commence ART in&#xD;
             pregnancy&#xD;
&#xD;
          -  ability and willingness to provide written informed consent&#xD;
&#xD;
          -  intent to remain in current geographical area of residence for the duration of study&#xD;
&#xD;
          -  willing to adhere to weekly study visit schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  confirmed prior spontaneous preterm birth&#xD;
&#xD;
          -  multiple gestation&#xD;
&#xD;
          -  known uterine anomaly&#xD;
&#xD;
          -  planned or in situ cervical cerclage&#xD;
&#xD;
          -  major fetal anomaly detected on screening ultrasound&#xD;
&#xD;
          -  indication for planned delivery prior to 37 weeks (e.g., prior classical cesarean)&#xD;
&#xD;
          -  threatened abortion, preterm labor, or ruptured membranes at time of enrollment&#xD;
&#xD;
          -  known allergy or medical comorbidity listed as a contraindication to 17P in the&#xD;
             prescribing information&#xD;
&#xD;
          -  prior participation in the trial&#xD;
&#xD;
          -  any other condition (social or medical) which, in the opinion of the study staff,&#xD;
             would make trial participation unsafe or complicate data interpretation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeff Stringer, MD, FACOG</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kamwala District Clinic</name>
      <address>
        <city>Lusaka</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Teaching Hospital</name>
      <address>
        <city>Lusaka</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zambia</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <results_first_submitted>May 7, 2021</results_first_submitted>
  <results_first_submitted_qc>June 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 9, 2021</results_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PreTerm Birth</keyword>
  <keyword>HIV-1-infection</keyword>
  <keyword>Antiretroviral Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>17 alpha-Hydroxyprogesterone Caproate</mesh_term>
    <mesh_term>11-hydroxyprogesterone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03297216/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>250 mg 17P</title>
          <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
17P: Synthetic progestin</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
Placebo: Non-active placebo comparator</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="399"/>
                <participants group_id="P2" count="401"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Discontinued Intervention</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Infants Born During Study</title>
              <participants_list>
                <participants group_id="P1" count="399"/>
                <participants group_id="P2" count="401"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="396"/>
                <participants group_id="P2" count="396"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscarriage</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mothers: 250 mg 17P</title>
          <description>Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
17P: Synthetic progestin</description>
        </group>
        <group group_id="B2">
          <title>Mothers: Placebo</title>
          <description>Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
Placebo: Non-active placebo comparator</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="399"/>
            <count group_id="B2" value="401"/>
            <count group_id="B3" value="800"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="399"/>
                    <measurement group_id="B2" value="401"/>
                    <measurement group_id="B3" value="800"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29" lower_limit="25" upper_limit="33"/>
                    <measurement group_id="B2" value="30" lower_limit="25" upper_limit="34"/>
                    <measurement group_id="B3" value="29" lower_limit="25" upper_limit="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="399"/>
                    <measurement group_id="B2" value="401"/>
                    <measurement group_id="B3" value="800"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="399"/>
                    <measurement group_id="B2" value="401"/>
                    <measurement group_id="B3" value="800"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="399"/>
                    <measurement group_id="B2" value="401"/>
                    <measurement group_id="B3" value="800"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Zambia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="399"/>
                    <measurement group_id="B2" value="401"/>
                    <measurement group_id="B3" value="800"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Experiencing Preterm Births or Stillbirths</title>
        <description>A composite of live births prior to 37 weeks of gestation or stillbirth occurring at any gestational age</description>
        <time_frame>At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths</time_frame>
        <population>Participants who received at least one injection of study product</population>
        <group_list>
          <group group_id="O1">
            <title>250 mg 17P</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Preterm Births or Stillbirths</title>
          <description>A composite of live births prior to 37 weeks of gestation or stillbirth occurring at any gestational age</description>
          <population>Participants who received at least one injection of study product</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="401"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Preterm Birth &lt;37 Weeks</title>
        <description>Delivery prior to 37 gestational weeks</description>
        <time_frame>At delivery, up to 37 weeks of gestation</time_frame>
        <population>Participants who received at least one injection of study product</population>
        <group_list>
          <group group_id="O1">
            <title>250 mg 17P</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Preterm Birth &lt;37 Weeks</title>
          <description>Delivery prior to 37 gestational weeks</description>
          <population>Participants who received at least one injection of study product</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="401"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Preterm Birth &lt;34 Weeks</title>
        <description>Delivery prior to 34 gestational weeks</description>
        <time_frame>At delivery, up to 34 weeks of gestation</time_frame>
        <population>Participants who received at least one injection of study product</population>
        <group_list>
          <group group_id="O1">
            <title>250 mg 17P</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Preterm Birth &lt;34 Weeks</title>
          <description>Delivery prior to 34 gestational weeks</description>
          <population>Participants who received at least one injection of study product</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="401"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Preterm Birth &lt;28 Weeks</title>
        <description>Delivery prior to 28 gestational weeks</description>
        <time_frame>At delivery, up to 28 weeks of gestation</time_frame>
        <population>Participants who received at least one injection of study product</population>
        <group_list>
          <group group_id="O1">
            <title>250 mg 17P</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Preterm Birth &lt;28 Weeks</title>
          <description>Delivery prior to 28 gestational weeks</description>
          <population>Participants who received at least one injection of study product</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="401"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Stillbirth</title>
        <description>Participants who had a fetus born without signs of life at any gestational age</description>
        <time_frame>At delivery, up to approximately 40 weeks of gestation</time_frame>
        <population>Participants who received at least one injection of study product</population>
        <group_list>
          <group group_id="O1">
            <title>250 mg 17P</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Stillbirth</title>
          <description>Participants who had a fetus born without signs of life at any gestational age</description>
          <population>Participants who received at least one injection of study product</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="401"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Spontaneous Delivery &lt;37 Weeks</title>
        <description>Delivery prior to 37 weeks of gestation that was initiated spontaneously, without provider intervention</description>
        <time_frame>At delivery, up to 37 weeks of gestation</time_frame>
        <population>Participants who received at least one injection of study product</population>
        <group_list>
          <group group_id="O1">
            <title>250 mg 17P</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Spontaneous Delivery &lt;37 Weeks</title>
          <description>Delivery prior to 37 weeks of gestation that was initiated spontaneously, without provider intervention</description>
          <population>Participants who received at least one injection of study product</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="401"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Spontaneous Delivery &lt;34 Weeks</title>
        <description>Delivery prior to 34 weeks of gestation that was initiated spontaneously, without provider intervention</description>
        <time_frame>At delivery, up to 34 weeks of gestation</time_frame>
        <population>Participants who received at least one injection of study product</population>
        <group_list>
          <group group_id="O1">
            <title>250 mg 17P</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>The study intervention started between 16-24 weeks gestation and administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Spontaneous Delivery &lt;34 Weeks</title>
          <description>Delivery prior to 34 weeks of gestation that was initiated spontaneously, without provider intervention</description>
          <population>Participants who received at least one injection of study product</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="401"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Spontaneous Delivery &lt;28 Weeks</title>
        <description>Delivery prior to 28 weeks of gestation that was initiated spontaneously, without provider intervention</description>
        <time_frame>At delivery, up to 28 weeks of gestation</time_frame>
        <population>Participants who received at least one injection of study product</population>
        <group_list>
          <group group_id="O1">
            <title>250 mg 17P</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Spontaneous Delivery &lt;28 Weeks</title>
          <description>Delivery prior to 28 weeks of gestation that was initiated spontaneously, without provider intervention</description>
          <population>Participants who received at least one injection of study product</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="401"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Infants With Birth Weight &lt;10th Percentile for Gestational Age</title>
        <description>Infant born with a weight below the 10th percentile for gestational age</description>
        <time_frame>Birth</time_frame>
        <population>Liveborn or stillborn infants weighed at birth</population>
        <group_list>
          <group group_id="O1">
            <title>250mg 17P</title>
            <description>Infant born to mother receiving weekly intramuscular injection of 250mg 17P&#xD;
17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Infant born to mother receiving weekly intramuscular injection of indistinguishable placebo&#xD;
Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Infants With Birth Weight &lt;10th Percentile for Gestational Age</title>
          <description>Infant born with a weight below the 10th percentile for gestational age</description>
          <population>Liveborn or stillborn infants weighed at birth</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="392"/>
                <count group_id="O2" value="394"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Infants With Birth Weight &lt;3rd Percentile for Gestational Age</title>
        <description>Infant born with a weight below the 3rd percentile for gestational age</description>
        <time_frame>Birth</time_frame>
        <population>Live born or stillborn infants weighed at birth</population>
        <group_list>
          <group group_id="O1">
            <title>250 mg 17P</title>
            <description>Infant born to mother receiving weekly intramuscular injection of 250mg 17P 17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Infant born to mother receiving weekly intramuscular injection of indistinguishable placebo Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Infants With Birth Weight &lt;3rd Percentile for Gestational Age</title>
          <description>Infant born with a weight below the 3rd percentile for gestational age</description>
          <population>Live born or stillborn infants weighed at birth</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="392"/>
                <count group_id="O2" value="394"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Infants Who Experienced Maternal-to-Child HIV Transmission</title>
        <description>Confirmed HIV infection in an infant</description>
        <time_frame>At 6 weeks of life</time_frame>
        <population>Infants receiving a test for early infant diagnosis at approximately 6 weeks postpartum</population>
        <group_list>
          <group group_id="O1">
            <title>250 mg 17P</title>
            <description>Infant born to mother receiving weekly intramuscular injection of 250mg 17P 17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Infant born to mother receiving weekly intramuscular injection of indistinguishable placebo Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Infants Who Experienced Maternal-to-Child HIV Transmission</title>
          <description>Confirmed HIV infection in an infant</description>
          <population>Infants receiving a test for early infant diagnosis at approximately 6 weeks postpartum</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="374"/>
                <count group_id="O2" value="379"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Neonatal Deaths</title>
        <description>Death of an infant following live birth</description>
        <time_frame>Birth through 28 days postpartum</time_frame>
        <population>Live born infants for whom follow-up information is available</population>
        <group_list>
          <group group_id="O1">
            <title>250 mg 17P</title>
            <description>Infant born to mother receiving weekly intramuscular injection of 250mg 17P 17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Infant born to mother receiving weekly intramuscular injection of indistinguishable placebo Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Neonatal Deaths</title>
          <description>Death of an infant following live birth</description>
          <population>Live born infants for whom follow-up information is available</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="388"/>
                <count group_id="O2" value="386"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Infants With 1-minute Apgar Score &lt;7</title>
        <description>Apgar score of less than 7 at 1 minute of life. Apgar stands for &quot;Appearance, Pulse, Grimace, Activity, and Respiration&quot; and is a quick test rated on a scale of 1-10 performed on a baby at one minute of life to determine how well the baby tolerated the birth process. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.</description>
        <time_frame>1 minute of life</time_frame>
        <population>Live born infants for whom an Apgar score was measured at 1 minute of life</population>
        <group_list>
          <group group_id="O1">
            <title>250 mg 17P</title>
            <description>Infant born to mother receiving weekly intramuscular injection of 250mg 17P 17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Infant born to mother receiving weekly intramuscular injection of indistinguishable placebo Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Infants With 1-minute Apgar Score &lt;7</title>
          <description>Apgar score of less than 7 at 1 minute of life. Apgar stands for &quot;Appearance, Pulse, Grimace, Activity, and Respiration&quot; and is a quick test rated on a scale of 1-10 performed on a baby at one minute of life to determine how well the baby tolerated the birth process. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.</description>
          <population>Live born infants for whom an Apgar score was measured at 1 minute of life</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="336"/>
                <count group_id="O2" value="338"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Infants With 5-minute Apgar Score &lt;7</title>
        <description>Apgar score of less than 7 at 5 minutes of life. Apgar stands for &quot;Appearance, Pulse, Grimace, Activity, and Respiration&quot; and is a quick test rated on a scale of 1-10 performed on a baby at five minutes of life to assess how well the baby is doing following delivery. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.</description>
        <time_frame>5 minutes of life</time_frame>
        <population>Live born infants for whom an Apgar score was measured at 5 minutes of life</population>
        <group_list>
          <group group_id="O1">
            <title>250 mg 17P</title>
            <description>Infant born to mother receiving weekly intramuscular injection of 250mg 17P 17P: Synthetic progestin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Infant born to mother receiving weekly intramuscular injection of indistinguishable placebo Placebo: Non-active placebo comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Infants With 5-minute Apgar Score &lt;7</title>
          <description>Apgar score of less than 7 at 5 minutes of life. Apgar stands for &quot;Appearance, Pulse, Grimace, Activity, and Respiration&quot; and is a quick test rated on a scale of 1-10 performed on a baby at five minutes of life to assess how well the baby is doing following delivery. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.</description>
          <population>Live born infants for whom an Apgar score was measured at 5 minutes of life</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mothers: 250 mg 17P</title>
          <description>Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
17P: Synthetic progestin</description>
        </group>
        <group group_id="E2">
          <title>Mothers: Placebo</title>
          <description>Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
Placebo: Non-active placebo comparator</description>
        </group>
        <group group_id="E3">
          <title>Infants Born to Mothers Receiving 250 mg 17P</title>
          <description>Infants born to mothers who started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
17P: Synthetic progestin</description>
        </group>
        <group group_id="E4">
          <title>Infants Born to Mothers Receiving Placebo</title>
          <description>Infants born to mothers who started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.&#xD;
Placebo: Non-active placebo comparator</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="399"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="401"/>
                <counts group_id="E3" subjects_affected="33" subjects_at_risk="399"/>
                <counts group_id="E4" subjects_affected="22" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <description>Low hemoglobin</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="399"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="401"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <description>Swelling in lower legs</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Neonatal Intestinal Obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Bowel Perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <description>Pain in the abdomen not necessarily associated with a specific diagnosis or etiology</description>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="399"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Neonatal Hypothermia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Neonatal Death of Unknown Cause</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Nose Bleed / Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Left Side Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Abdominal Trauma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>General Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Neonatal Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Neonatal Jaundice</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Malaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Presumed Neonatal Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="399"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Pulmonary Tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Neonatal Hypoglecemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neonatal Encephelopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="399"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Eclampsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Hemorrhage</sub_title>
                <description>Antepartum or postpartum</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="399"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <description>Pregnancy induced and postpartum hypertension</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="399"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Premature Rupture of Membranes</sub_title>
                <description>Preterm or Term</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="399"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Preeclampsia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="399"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Preterm labor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Puerperal Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Stillbirth</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="399"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Cesarean Scar Tenderness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Placental Abruption</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Prematurity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Presumed Psychosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="399"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Kidney Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Bladder Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Neonatal Respiratory Distress Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E3" events="14" subjects_affected="14" subjects_at_risk="399"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="401"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="26" subjects_affected="25" subjects_at_risk="399"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="399"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="401"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Joan Price, MD, MPH</name_or_title>
      <organization>University of North Carolina at Chapel Hill</organization>
      <phone>919-962-4717</phone>
      <email>joan_price@med.unc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03297216
org study id: 17-1173
secondary id: 1R01HD087119
nct id: NCT03297216
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking
      place in Zambia.
Weekly intramuscular injections of 250mg 17-alpha hydroxyprogesterone caproate (17P) or
      indistinguishable placebo will be randomly allocated in a 1:1 ratio started between 16-24
      weeks gestation and administered weekly thereafter until 36 6/7 gestational weeks,
      stillbirth, or delivery, whichever is sooner.

      Individual participants will be followed from enrollment (prior to 24 weeks gestation)
      through 42 days postpartum.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Phase III, double-masked, placebo-controlled, randomized controlled trial
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of Participants Experiencing Preterm Births or Stillbirths
time frame: At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths
description: A composite of live births prior to 37 weeks of gestation or stillbirth occurring at any gestational age
measure: Number of Participants Experiencing Preterm Birth <37 Weeks
time frame: At delivery, up to 37 weeks of gestation
description: Delivery prior to 37 gestational weeks
measure: Number of Participants Experiencing Preterm Birth <34 Weeks
time frame: At delivery, up to 34 weeks of gestation
description: Delivery prior to 34 gestational weeks
measure: Number of Participants Experiencing Preterm Birth <28 Weeks
time frame: At delivery, up to 28 weeks of gestation
description: Delivery prior to 28 gestational weeks
measure: Number of Participants Experiencing Stillbirth
time frame: At delivery, up to approximately 40 weeks of gestation
description: Participants who had a fetus born without signs of life at any gestational age
measure: Number of Participants Experiencing Spontaneous Delivery <37 Weeks
time frame: At delivery, up to 37 weeks of gestation
description: Delivery prior to 37 weeks of gestation that was initiated spontaneously, without provider intervention
measure: Number of Participants Experiencing Spontaneous Delivery <34 Weeks
time frame: At delivery, up to 34 weeks of gestation
description: Delivery prior to 34 weeks of gestation that was initiated spontaneously, without provider intervention
measure: Number of Participants Experiencing Spontaneous Delivery <28 Weeks
time frame: At delivery, up to 28 weeks of gestation
description: Delivery prior to 28 weeks of gestation that was initiated spontaneously, without provider intervention
measure: Number of Infants With Birth Weight <10th Percentile for Gestational Age
time frame: Birth
description: Infant born with a weight below the 10th percentile for gestational age
measure: Number of Infants With Birth Weight <3rd Percentile for Gestational Age
time frame: Birth
description: Infant born with a weight below the 3rd percentile for gestational age
measure: Number of Infants Who Experienced Maternal-to-Child HIV Transmission
time frame: At 6 weeks of life
description: Confirmed HIV infection in an infant
measure: Number of Neonatal Deaths
time frame: Birth through 28 days postpartum
description: Death of an infant following live birth
measure: Number of Infants With 1-minute Apgar Score <7
time frame: 1 minute of life
description: Apgar score of less than 7 at 1 minute of life. Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration" and is a quick test rated on a scale of 1-10 performed on a baby at one minute of life to determine how well the baby tolerated the birth process. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
measure: Number of Infants With 5-minute Apgar Score <7
time frame: 5 minutes of life
description: Apgar score of less than 7 at 5 minutes of life. Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration" and is a quick test rated on a scale of 1-10 performed on a baby at five minutes of life to assess how well the baby is doing following delivery. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
arm group label: 250 mg 17P
arm group type: Active Comparator
description: weekly intramuscular injection of 250mg 17P
arm group label: Placebo
arm group type: Placebo Comparator
description: weekly intramuscular injection of indistinguishable placebo
intervention type: Drug
intervention name: 17P
description: Synthetic progestin
arm group label: 250 mg 17P
other name: 17-alpha hydroxyprogesterone caproate
intervention type: Other
intervention name: Placebo
description: Non-active placebo comparator
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeff Stringer, MD, FACOG
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
facility: 
country: Zambia
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: 17 alpha-Hydroxyprogesterone Caproate
mesh term: 11-hydroxyprogesterone
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 