Effect of Antenatal Corticosteroids in Late Preterm

• Sponsor: Meir Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01710384
• Collaborator: (none)
• Enrollment: 200
• Arms: 2
• Duration (Months): 36

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Late Preterm	Drug: betamethasone	Phase 2

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

4. Premature rupture of membranes 2. Fetus with known defects 3. Suspicion of fetal distress

5. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2012
• Anticipated Primary Completion Date: Nov 1, 2014
• Anticipated Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: betamethasoneb, 34-36 weeks, preterm labor betamethasone 12 mg 2 injections will be given 24-hours apart.	Drug: betamethasone
No Intervention: preterm labor, 34-37 weeks betamethasone 12 mg 2 injections will be given 24-hours apart.

Outcome Measures

Primary Outcome Measures

1. neonate respiratory distress syndrome [1 year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Meir Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Meir Medical Center
• ClinicalTrials.gov Identifier: NCT01710384
• Other Study ID Numbers: 006111
• First Posted: Oct 19, 2012
• Last Update Posted: Oct 19, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Meir Medical Center: late preterm, betamethasone,
• Additional relevant MeSH terms: Premature Birth; Betamethasone

Study Results

No Results Posted as of Oct 19, 2012