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

About this trial
This is an interventional treatment trial for Late Preterm focused on measuring late preterm, betamethasone,
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
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
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
Learn more about this trial
Effect of Antenatal Corticosteroids in Late Preterm
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