Official Title: “A Randomized Placebo-Controlled Trial of Antenatal Corticosteroid Regimens”

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.

Study Type: Interventional

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

Study Primary Completion Date: May 2006

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.

Intervention(s) in this Clinical Trial

• Drug: Betamethasone
  • coded study medication is 12 mg of betamethasone (or placebo) given as 2 ml intramuscular injection in 2 doses, 24 hours apart (the "Course"). Patients administered weekly courses for 4 weeks, until 33 weeks 6 days gestation or delivery, whichever occurs first.

Primary Measures

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

Secondary Measures

• Neonatal morbidity
• Maternal morbidity
• Neonatal Growth parameters
• Infant neurological parameters

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute of Child Health and Human Development (NICHD)

Overall Clinical Trial Officials and Contacts

Ronald J Wapner, MD Principal Investigator MCP Hahnemann University Hospital  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00015002

Study ID Number: NICHD-0801

ClinicalTrials.gov Identifier: NCT00015002

Health Authority: United States: Federal Government

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