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Effect of Antenatal Corticosteroids in Late Preterm

Primary Purpose

Late Preterm

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
betamethasone
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Late Preterm focused on measuring late preterm, betamethasone,

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    betamethasoneb, 34-36 weeks, preterm labor

    preterm labor, 34-37 weeks

    Arm Description

    betamethasone 12 mg 2 injections will be given 24-hours apart.

    betamethasone 12 mg 2 injections will be given 24-hours apart.

    Outcomes

    Primary Outcome Measures

    neonate respiratory distress syndrome

    Secondary Outcome Measures

    1 and 5 minute Apgar scores, and complications during the first week of life, including hypoglycemia, seizures, intubation or medications

    Full Information

    First Posted
    October 17, 2012
    Last Updated
    October 17, 2012
    Sponsor
    Meir Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01710384
    Brief Title
    Effect of Antenatal Corticosteroids in Late Preterm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    November 2014 (Anticipated)
    Study Completion Date
    November 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Meir Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To test the effect on premature infants of a one-time course of betamethasone administered in weeks 34-36 of gestation.
    Detailed Description
    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 Pregnant woman in weeks 34-36 of gestation who did not receive a betamethasone course to enhance fetal lung maturity during pregnancy Clinical, sonographic or laboratory suspicion of premature labor 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Late Preterm
    Keywords
    late preterm, betamethasone,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    betamethasoneb, 34-36 weeks, preterm labor
    Arm Type
    Experimental
    Arm Description
    betamethasone 12 mg 2 injections will be given 24-hours apart.
    Arm Title
    preterm labor, 34-37 weeks
    Arm Type
    No Intervention
    Arm Description
    betamethasone 12 mg 2 injections will be given 24-hours apart.
    Intervention Type
    Drug
    Intervention Name(s)
    betamethasone
    Primary Outcome Measure Information:
    Title
    neonate respiratory distress syndrome
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    1 and 5 minute Apgar scores, and complications during the first week of life, including hypoglycemia, seizures, intubation or medications
    Time Frame
    1 week

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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: Premature rupture of membranes Fetus with known defects Suspicion of fetal distress Betamethasone administered during pregnancy for any reason

    12. IPD Sharing Statement

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