Effect of Antenatal Corticosteroids in Late Preterm

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

Study Overview

• Status: Unknown
• Conditions: Late Preterm
• Intervention / Treatment: Drug: betamethasone

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

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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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
neonate respiratory distress syndrome	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): November 1, 2014
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: October 17, 2012
• First Submitted That Met QC Criteria: October 17, 2012
• First Posted (Estimate): October 19, 2012

Study Record Updates

• Last Update Posted (Estimate): October 19, 2012
• Last Update Submitted That Met QC Criteria: October 17, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: late preterm, betamethasone,
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone
• Other Study ID Numbers: 006111