Repeat Antenatal Steroids Trial - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 17, 2001

Last Updated Date

February 9, 2009

Start Date ^†

March 2000

Current Primary Outcome Measures ^†

Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00015002 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Neonatal morbidity
Maternal morbidity
Neonatal Growth parameters
Infant neurological parameters

Original Secondary Outcome Measures ^†

Neonatal morbidity
Maternal morbidity
Neonatal Growth parameters
Infant neurological parameters

Descriptive Information

Brief Title ^†

Repeat Antenatal Steroids Trial

Official Title ^†

A Randomized Placebo-Controlled Trial of Antenatal Corticosteroid Regimens

Brief Summary

A course of steroids given to a mother who is in labor with a premature fetus will reduce the risk of the premature infant dying or having serious complications. This trial will test whether more than one course of antenatal steroids is more beneficial or risky to the infant than a single course.

Detailed Description

After the NICHD Consensus Development Conference in 1994, the antenatal administration of antenatal corticosteroids (betamethasone or dexamethasone) for prevention of death and the serious morbidities associated with preterm birth has become an accepted standard in American obstetric practice. Studies have shown that maximum beneficial effect occurs when the fetus is delivered within 7 days of antenatal steroid administration. The efficacy and safety of a single course of corticosteroids has been substantiated but it is unknown whether repetitive dosing has similar efficacy or what the maternal, fetal and neonatal risks are. Repeat courses of steroids are often administered. Two popular regimens exist for the patient who remains undelivered more than one week after initial therapy but who remains at risk for preterm birth. In one, steroids are repeated weekly until 34 weeks gestation, while in the other, steroids are only given once.

This multicenter trial is testing the safety and efficacy of weekly administration of antenatal steroids. Twenty four hundred women < 32.0 weeks gestation who are at risk for spontaneous preterm delivery and remain pregnant at least seven days after an initial course of corticosteroids are being randomized to either weekly courses of masked study drug (betamethasone or placebo) for 4 weeks or delivery, whichever comes first. Patients are asked about side effects at the weekly visits and samples of maternal blood at randomization and delivery are collected. Cord blood and placentas are also collected. Cranial ultrasounds are done on all neonates. On a subgroup of patients, an adrenocorticotrophic hormone (ACTH) stimulation test is being performed and an auditory brainstem response (ABR) performed. All infants attend a follow-up visit at 18 to 22 months corrected age where certified examiners, masked to study group assignment, collect physical and neurological data. The Bayley Scales of Infant Development will also be administered.

A subgroup of infants will be seen at 36 months to administer the Intelligence scale from the McCarthy Scales of Children's Abilities.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Efficacy Study

Condition ^†

Complications, Pregnancy

Intervention ^†

Drug: Betamethasone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

486

Completion Date

March 2007

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion criteria:

Pregnant
Gestational age > 23.0 wks and < 31.6 wks
Singleton or twin pregnancy
Intact membranes
At-risk for spontaneous preterm delivery
Received full course of corticosteroids within the previous 7 days

Exclusion criteria:

Diagnosis of fetal lung maturity
Chorioamnionitis
Non-reassuring fetal testing
Known major fetal anomaly
Corticosteroid therapy, other than qualifying course
Insulin dependent diabetes
Active preterm labor at the time of randomization
Delivery intended outside center
Participation in any intervention study which influences neonatal morbidity or mortality
Previous participation in this trial

Gender

Female

Ages

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00015002

Responsible Party

Catherine Y Spong, MD, Chief, Pregnancy and Perinatology Branch, NICHD, NIH

Secondary IDs ^††

HD21410, HD27869, HD27917, HD27860, HD27915, HD34116, HD34208, HD34136, HD40500, HD40485, HD40544, HD40545, HD40560, HD40512, HD36801

Study Sponsor ^†

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators ^††

Investigators ^†

Principal Investigator:

Ronald J Wapner, MD

MCP Hahnemann University Hospital

Information Provided By

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.