<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/NCT01710384</url>
  </required_header>
  <id_info>
    <org_study_id>006111</org_study_id>
    <nct_id>NCT01710384</nct_id>
  </id_info>
  <brief_title>Effect of Antenatal Corticosteroids in Late Preterm</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To test the effect on premature infants of a one-time course of betamethasone administered in&#xD;
      weeks 34-36 of gestation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Protocol version 3, 1/7/2012&#xD;
&#xD;
      Research Goal To test the effect on premature infants of a one-time course of betamethasone&#xD;
      administered in weeks 34-36 of gestation.&#xD;
&#xD;
      Inclusion criteria&#xD;
&#xD;
        1. Pregnant woman in weeks 34-36 of gestation who did not receive a betamethasone course to&#xD;
           enhance fetal lung maturity during pregnancy&#xD;
&#xD;
        2. Clinical, sonographic or laboratory suspicion of premature labor&#xD;
&#xD;
        3. Singleton or twin pregnancy Exclusion criteria&#xD;
&#xD;
      1. Premature rupture of membranes 2. Fetus with known defects 3. Suspicion of fetal distress&#xD;
      4. Betamethasone administered during pregnancy for any reason Research protocol Study group&#xD;
      100 women in weeks 34-36 of gestation with clinical, sonographic or laboratory suspicion of&#xD;
      early labor will be recruited.&#xD;
&#xD;
      Demographic data will be collected, including full medical and obstetrical anamnesis.&#xD;
&#xD;
      After full obstetric analysis, including monitoring, sonographic and lab tests as needed for&#xD;
      each case and as determined by department policy, a full course of 2 injections of&#xD;
      betamethasone will be given 24-hours apart.&#xD;
&#xD;
      After birth, data will be collected on the delivery, including birth week, method (vaginal,&#xD;
      cesarean, forceps, etc.), obstetric complications (abruption of the placenta, Premature&#xD;
      rupture of membranes, preeclampsia, etc.). Data on the neonate, including birth weight, 1 and&#xD;
      5 minute Apgar scores, and complications during the first week of life, including&#xD;
      hypoglycemia, seizures, intubation or medications will also be collected.&#xD;
&#xD;
      Prospective control group 100 women will be recruited who delivered in the hospital during&#xD;
      the study period in weeks 34-37 of pregnancy, who did not receive a course of betamethasone&#xD;
      during pregnancy.&#xD;
&#xD;
      Demographic data will be collected, full medical and obstetric anamnesis including current&#xD;
      and previous pregnancies.&#xD;
&#xD;
      After birth, data will be collected on the delivery, including birth week, method (vaginal,&#xD;
      cesarean, forceps, etc.), obstetric complications (abruption of the placenta, Premature&#xD;
      rupture of membranes, preeclampsia, etc.). Data on the neonate, including birth weight, 1 and&#xD;
      5 minute Apgar scores, and complications during the first week of life, including&#xD;
      hypoglycemia, seizures, intubation or medications will also be collected.&#xD;
&#xD;
      Data will be collected over a one-year period. Retrospective control group 200 women who&#xD;
      delivered from 2009 to 2011, in weeks 34-37 of gestation who did not receive a course of&#xD;
      betamethasone during the pregnancy.&#xD;
&#xD;
      Data will be anonymously collected from medical records, including demographics and full&#xD;
      medical and obstetric anamnesis.&#xD;
&#xD;
      After birth, data will be collected on the delivery, including birth week, method (vaginal,&#xD;
      cesarean, forceps, etc.), obstetric complications (abruption of the placenta, Premature&#xD;
      rupture of membranes, preeclampsia, etc.). Data on the neonate, including birth weight, 1 and&#xD;
      5 minute Apgar scores, and complications during the first week of life, including&#xD;
      hypoglycemia, seizures, intubation or medications will also be collected.&#xD;
&#xD;
      The pregnancy and neonatal outcomes among the groups of women who received and did not&#xD;
      receive betamethasone will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Anticipated">November 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>neonate respiratory distress syndrome</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>1 and 5 minute Apgar scores, and complications during the first week of life, including hypoglycemia, seizures, intubation or medications</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Late Preterm</condition>
  <arm_group>
    <arm_group_label>betamethasoneb, 34-36 weeks, preterm labor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>betamethasone 12 mg 2 injections will be given 24-hours apart.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>preterm labor, 34-37 weeks</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>betamethasone 12 mg 2 injections will be given 24-hours apart.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>betamethasone</intervention_name>
    <arm_group_label>betamethasoneb, 34-36 weeks, preterm labor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Pregnant woman in weeks 34-36 of gestation who did not receive a betamethasone course to&#xD;
        enhance fetal lung maturity during pregnancy 2. Clinical, sonographic or laboratory&#xD;
        suspicion of premature labor 3. Singleton or twin pregnancy&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Premature rupture of membranes&#xD;
&#xD;
          2. Fetus with known defects&#xD;
&#xD;
          3. Suspicion of fetal distress&#xD;
&#xD;
          4. Betamethasone administered during pregnancy for any reason&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>October 17, 2012</last_update_submitted>
  <last_update_submitted_qc>October 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>late preterm, betamethasone,</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>Betamethasone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01710384
org study id: 006111
nct id: NCT01710384
lead sponsor: 
has dmc: Yes
To test the effect on premature infants of a one-time course of betamethasone administered in
      weeks 34-36 of gestation.
Protocol version 3, 1/7/2012

      Research Goal To test the effect on premature infants of a one-time course of betamethasone
      administered in weeks 34-36 of gestation.

      Inclusion criteria

        1. Pregnant woman in weeks 34-36 of gestation who did not receive a betamethasone course to
           enhance fetal lung maturity during pregnancy

        2. Clinical, sonographic or laboratory suspicion of premature labor

        3. Singleton or twin pregnancy Exclusion criteria

      1. Premature rupture of membranes 2. Fetus with known defects 3. Suspicion of fetal distress
      4. Betamethasone administered during pregnancy for any reason Research protocol Study group
      100 women in weeks 34-36 of gestation with clinical, sonographic or laboratory suspicion of
      early labor will be recruited.

      Demographic data will be collected, including full medical and obstetrical anamnesis.

      After full obstetric analysis, including monitoring, sonographic and lab tests as needed for
      each case and as determined by department policy, a full course of 2 injections of
      betamethasone will be given 24-hours apart.

      After birth, data will be collected on the delivery, including birth week, method (vaginal,
      cesarean, forceps, etc.), obstetric complications (abruption of the placenta, Premature
      rupture of membranes, preeclampsia, etc.). Data on the neonate, including birth weight, 1 and
      5 minute Apgar scores, and complications during the first week of life, including
      hypoglycemia, seizures, intubation or medications will also be collected.

      Prospective control group 100 women will be recruited who delivered in the hospital during
      the study period in weeks 34-37 of pregnancy, who did not receive a course of betamethasone
      during pregnancy.

      Demographic data will be collected, full medical and obstetric anamnesis including current
      and previous pregnancies.

      After birth, data will be collected on the delivery, including birth week, method (vaginal,
      cesarean, forceps, etc.), obstetric complications (abruption of the placenta, Premature
      rupture of membranes, preeclampsia, etc.). Data on the neonate, including birth weight, 1 and
      5 minute Apgar scores, and complications during the first week of life, including
      hypoglycemia, seizures, intubation or medications will also be collected.

      Data will be collected over a one-year period. Retrospective control group 200 women who
      delivered from 2009 to 2011, in weeks 34-37 of gestation who did not receive a course of
      betamethasone during the pregnancy.

      Data will be anonymously collected from medical records, including demographics and full
      medical and obstetric anamnesis.

      After birth, data will be collected on the delivery, including birth week, method (vaginal,
      cesarean, forceps, etc.), obstetric complications (abruption of the placenta, Premature
      rupture of membranes, preeclampsia, etc.). Data on the neonate, including birth weight, 1 and
      5 minute Apgar scores, and complications during the first week of life, including
      hypoglycemia, seizures, intubation or medications will also be collected.

      The pregnancy and neonatal outcomes among the groups of women who received and did not
      receive betamethasone will be evaluated.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: neonate respiratory distress syndrome
time frame: 1 year
measure: 1 and 5 minute Apgar scores, and complications during the first week of life, including hypoglycemia, seizures, intubation or medications
time frame: 1 week
arm group label: betamethasoneb, 34-36 weeks, preterm labor
arm group type: Experimental
description: betamethasone 12 mg 2 injections will be given 24-hours apart.
arm group label: preterm labor, 34-37 weeks
arm group type: No Intervention
description: betamethasone 12 mg 2 injections will be given 24-hours apart.
intervention type: Drug
intervention name: betamethasone
arm group label: betamethasoneb, 34-36 weeks, preterm labor
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Betamethasone