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.

Condition	Treatment or Intervention	Phase
Complications, Pregnancy	Drug: corticosteroids	Phase III

Further Study Details: 

Expected Total Enrollment:  2400

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.

Genders Eligible for Study:  Female

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

Catherine Spong, MD      301-435-6894    spongc@mail.nih.gov

Michigan
      Dept of OB/GYN, Hutzel Hospital, Detroit,  Michigan,  48201,  United States; Recruiting
North Carolina
      Forsyth Memorial Hospital, Wake Forest University School of Medicine, Winston Salem,  North Carolina,  27103,  United States; Recruiting
Ohio
      Dept of OB/GYN, Ohio State University, Columbus,  Ohio,  43210,  United States; Recruiting
Pennsylvania
      Dept of OB/GYN, Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
      Thomas Jefferson University Medical Center, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
Texas
      Dept of OB/GYN, Southwestern Medical Center, University of Texas, Dallas,  Texas,  75235-9032,  United States; Recruiting
Utah
      University of Utah Medical Center, Salt Lake City,  Utah,  84132,  United States; Recruiting

Study chairs or principal investigators

Ronald J Wapner, MD,  Principal Investigator,  MCP Hahnemann University Hospital   

Study ID Numbers:  NICHD-0801; U10-HD21410; U10-HD27917; U10-HD27860; U10-HD27915; U10-HD34116; U10-HD40600; U10-HD34136
Record last reviewed:  March 2003
Last Updated:  October 13, 2004
Record first received:  April 17, 2001
ClinicalTrials.gov Identifier:  NCT00015002
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08