<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/NCT01733329</url>
  </required_header>
  <id_info>
    <org_study_id>GI07-011</org_study_id>
    <nct_id>NCT01733329</nct_id>
  </id_info>
  <brief_title>Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage</brief_title>
  <official_title>Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario Dr. Jose E. Gonzalez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario Dr. Jose E. Gonzalez</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: to demonstrate that buccal misoprostol administration during cesarean delivery in&#xD;
      women with risk factors for uterine atony decreases the need for additional uterotonic&#xD;
      medications, uterine atony and postpartum hemorrhage.&#xD;
&#xD;
      Design: randomized, double-blinded, placebo-controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients and methods: 120 pregnant women with risk factors for uterine atony who underwent&#xD;
      cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo&#xD;
      (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables&#xD;
      were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2008</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Need for Additional Uterotonic Medications</measure>
    <time_frame>24 hours</time_frame>
    <description>The surgeon requested additional uterotonic agents on the basis of the clinical findings during surgery (e.g. uterine atony or blood loss of at least 1000 mL) Additional oxytocin was considered additional oxytocic intervention for purposes of data analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uterine Atony</measure>
    <time_frame>24 hours</time_frame>
    <description>Uterine atony is defined as failure of the uterus to contract adequately following delivery. Recognition of a soft, &quot;boggy&quot; uterus in the setting of excessive postpartum bleeding can alert the attendant to atony and should trigger a series of interventions aimed at achieving tonic sustained uterine contraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum Hemorrhage</measure>
    <time_frame>24 HOURS</time_frame>
    <description>Defined as:&#xD;
Estimated blood loss ≥1000 mL after cesarean delivery. A substantial fall in the haematocrit e.g. 10% The requirement for a blood transfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Loss</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Misoprostol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to 400 mcg misoprostol (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Folic Acid</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to 10 mg Folic acid (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.</description>
    <arm_group_label>Misoprostol</arm_group_label>
    <other_name>Cytotec</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folic Acid</intervention_name>
    <description>At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.</description>
    <arm_group_label>Folic Acid</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who underwent delivery either by elective or emergent cesarean section at 24&#xD;
             week gestation or later with preoperative levels of hemoglobin and hematocrit&#xD;
             determined up to 72 hours prior to delivery. The patients must have at least one of&#xD;
             the risk factors for uterine atony listed below:&#xD;
&#xD;
               1. Fetal macrosomia (estimated fetal weight ≥ 4 Kilos) diagnosed by clinical&#xD;
                  measurement (Johnson´s technique) or ultrasound measurement (Hadlock´s formula).&#xD;
&#xD;
               2. Polyhydramnios (defined as Phelan´s amniotic fluid index &gt; 24 cm)&#xD;
&#xD;
               3. Twin or Multiple pregnancy.&#xD;
&#xD;
               4. Prolonged labour (prolonged active phase &gt; 12 hours) or precipitate&#xD;
                  labour(cervical dilatation ≥ 10 cm/hour).&#xD;
&#xD;
               5. Magnesium sulphate or any other tocolytic agent therapy for ≥ 8 hours before&#xD;
                  cesarean section.&#xD;
&#xD;
               6. Intravenous oxytocin therapy for at least 4 hours before cesarean section.&#xD;
&#xD;
               7. Multiparous women (≥ 3 prior abdominal or vaginal deliveries )&#xD;
&#xD;
               8. Clinical chorioamnionitis was defined as maternal temperature of ≥ 38°C in&#xD;
                  addition to more than one of the following criteria: fetal tachycardia (&gt; 160&#xD;
                  beats per minute), maternal tachycardia (&gt;100 beats per minute, maternal&#xD;
                  leukocytosis (15,000 cells/mm3), uterine tenderness or foul smelling amniotic&#xD;
                  fluid.&#xD;
&#xD;
               9. Known myomatosis, uterine Müllerian malformations or those diagnosed by&#xD;
                  ultrasound.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Misoprostol incorrect administration&#xD;
&#xD;
          2. Severe allergic, bleeding disorders (e.g., haemophilia); severe asthma or any other&#xD;
             absolute contraindication to misoprostol use.&#xD;
&#xD;
          3. Any bleeding occurred before delivery (abruptio placentae, placenta praevia) or&#xD;
             bleeding due to other causes different than uterine atony.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Universitario Dr. José Eleuterio González</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Hamm J, Russell Z, Botha T, Carlan SJ, Richichi K. Buccal misoprostol to prevent hemorrhage at cesarean delivery: a randomized study. Am J Obstet Gynecol. 2005 May;192(5):1404-6. doi: 10.1016/j.ajog.2004.12.033.</citation>
    <PMID>15902121</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <results_first_submitted>December 14, 2013</results_first_submitted>
  <results_first_submitted_qc>February 12, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 31, 2014</results_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario Dr. Jose E. Gonzalez</investigator_affiliation>
    <investigator_full_name>Flavio Hernández Castro</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Buccal Misoprostol</keyword>
  <keyword>Uterine Atony</keyword>
  <keyword>Postpartum Hemorrhage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Folic Acid</mesh_term>
    <mesh_term>Misoprostol</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Misoprostol</title>
          <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=62) or placebo (n=61) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Misoprostol</description>
        </group>
        <group group_id="P2">
          <title>Folic Acid</title>
          <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Uterine artery injury</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Misoprostol</title>
          <description>women with risk factors for uterine atony who underwent cesarean delivery assigned randomly to 400 mcg misoprostol (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Misoprostol</description>
        </group>
        <group group_id="B2">
          <title>Folic Acid</title>
          <description>women with risk factors for uterine atony who underwent cesarean delivery assigned randomly to 10 mg Folic acid (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist . The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Placebo</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="62"/>
            <count group_id="B2" value="61"/>
            <count group_id="B3" value="123"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.05" spread="5.32"/>
                    <measurement group_id="B2" value="25.18" spread="6.29"/>
                    <measurement group_id="B3" value="24.62" spread="5.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="112"/>
                  </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>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="62"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="123"/>
                  </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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Need for Additional Uterotonic Medications</title>
        <description>The surgeon requested additional uterotonic agents on the basis of the clinical findings during surgery (e.g. uterine atony or blood loss of at least 1000 mL) Additional oxytocin was considered additional oxytocic intervention for purposes of data analysis.</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Misoprostol</title>
            <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Misoprostol</description>
          </group>
          <group group_id="O2">
            <title>Folic Acid</title>
            <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Need for Additional Uterotonic Medications</title>
          <description>The surgeon requested additional uterotonic agents on the basis of the clinical findings during surgery (e.g. uterine atony or blood loss of at least 1000 mL) Additional oxytocin was considered additional oxytocic intervention for purposes of data analysis.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Uterine Atony</title>
        <description>Uterine atony is defined as failure of the uterus to contract adequately following delivery. Recognition of a soft, &quot;boggy&quot; uterus in the setting of excessive postpartum bleeding can alert the attendant to atony and should trigger a series of interventions aimed at achieving tonic sustained uterine contraction.</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Misoprostol</title>
            <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Misoprostol</description>
          </group>
          <group group_id="O2">
            <title>Folic Acid</title>
            <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Uterine Atony</title>
          <description>Uterine atony is defined as failure of the uterus to contract adequately following delivery. Recognition of a soft, &quot;boggy&quot; uterus in the setting of excessive postpartum bleeding can alert the attendant to atony and should trigger a series of interventions aimed at achieving tonic sustained uterine contraction.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.026</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postpartum Hemorrhage</title>
        <description>Defined as:&#xD;
Estimated blood loss ≥1000 mL after cesarean delivery. A substantial fall in the haematocrit e.g. 10% The requirement for a blood transfusion</description>
        <time_frame>24 HOURS</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Misoprostol</title>
            <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Misoprostol</description>
          </group>
          <group group_id="O2">
            <title>Folic Acid</title>
            <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Postpartum Hemorrhage</title>
          <description>Defined as:&#xD;
Estimated blood loss ≥1000 mL after cesarean delivery. A substantial fall in the haematocrit e.g. 10% The requirement for a blood transfusion</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.058</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Loss</title>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Misoprostol</title>
            <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Misoprostol</description>
          </group>
          <group group_id="O2">
            <title>Folic Acid</title>
            <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Loss</title>
          <units>mL</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="470" spread="149.91"/>
                    <measurement group_id="O2" value="653.33" spread="342.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.007</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Misoprostol</title>
          <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Misoprostol</description>
        </group>
        <group group_id="E2">
          <title>Folic Acid</title>
          <description>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.&#xD;
Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </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>
    <limitations_and_caveats>Technical problems with blood loss measurement leading to blood transfusion before receiving hematocrit result.&#xD;
Small number of patients fulfill inclusion criteria.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Flavio Hernández Castro</name_or_title>
      <organization>Hospital Universitario José Eleuterio González, Universidad Autónoma de Nuevo León</organization>
      <phone>8112776459</phone>
      <email>flaviohernandezc@yahoo.com</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/NCT01733329
org study id: GI07-011
nct id: NCT01733329
lead sponsor: 
has dmc: Yes
Objective: to demonstrate that buccal misoprostol administration during cesarean delivery in
      women with risk factors for uterine atony decreases the need for additional uterotonic
      medications, uterine atony and postpartum hemorrhage.

      Design: randomized, double-blinded, placebo-controlled trial.
Patients and methods: 120 pregnant women with risk factors for uterine atony who underwent
      cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo
      (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables
      were the need for additional uterotonic agents, estimated blood loss and uterine atony.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Need for Additional Uterotonic Medications
time frame: 24 hours
description: The surgeon requested additional uterotonic agents on the basis of the clinical findings during surgery (e.g. uterine atony or blood loss of at least 1000 mL) Additional oxytocin was considered additional oxytocic intervention for purposes of data analysis.
measure: Uterine Atony
time frame: 24 hours
description: Uterine atony is defined as failure of the uterus to contract adequately following delivery. Recognition of a soft, "boggy" uterus in the setting of excessive postpartum bleeding can alert the attendant to atony and should trigger a series of interventions aimed at achieving tonic sustained uterine contraction.
measure: Postpartum Hemorrhage
time frame: 24 HOURS
description: Defined as:
Estimated blood loss ≥1000 mL after cesarean delivery. A substantial fall in the haematocrit e.g. 10% The requirement for a blood transfusion
measure: Blood Loss
time frame: 24 hours
arm group label: Misoprostol
arm group type: Experimental
description: women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to 400 mcg misoprostol (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
arm group label: Folic Acid
arm group type: Placebo Comparator
description: women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to 10 mg Folic acid (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
intervention type: Drug
intervention name: Misoprostol
description: At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.
arm group label: Misoprostol
other name: Cytotec
intervention type: Drug
intervention name: Folic Acid
description: At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.
arm group label: Folic Acid
other name: Placebo
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Mexico
citation: Hamm J, Russell Z, Botha T, Carlan SJ, Richichi K. Buccal misoprostol to prevent hemorrhage at cesarean delivery: a randomized study. Am J Obstet Gynecol. 2005 May;192(5):1404-6. doi: 10.1016/j.ajog.2004.12.033.
PMID: 15902121
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario Dr. Jose E. Gonzalez
investigator full name: Flavio Hernández Castro
investigator title: Principal Investigator
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Folic Acid
mesh term: Misoprostol
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Technical problems with blood loss measurement leading to blood transfusion before receiving hematocrit result.
Small number of patients fulfill inclusion criteria.
point of contact: 