Effect of Antenatal Corticosteroids in Late Preterm

Phase 2

• Conditions: Late Preterm
• Interventions: Drug: betamethasone

• Registration Number: NCT01710384
• Lead Sponsor: Meir Medical Center

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

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.

Study Timeline

• Status Verified: 2012-10
• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-17
• Last Update Submitted: 2012-10-17
• Study First Posted: 2012-10-19
• Last Update Posted: 2012-10-19
• Study Start: 2012-11
• Primary Completion: 2014-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
betamethasoneb, 34-36 weeks, preterm labor	betamethasone	betamethasone 12 mg 2 injections will be given 24-hours apart.

Primary Outcome Measures

Name	Time	Method
neonate respiratory distress syndrome	1 year

Secondary Outcome Measures

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