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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00015002 |
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 | Intervention | Phase |
---|---|---|
Complications, Pregnancy |
Drug: Betamethasone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Randomized Placebo-Controlled Trial of Antenatal Corticosteroid Regimens |
Enrollment: | 486 |
Study Start Date: | March 2000 |
Study Completion Date: | March 2007 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
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 |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
United States, Alabama | |
University of Alabama | |
Birmingham, Alabama, United States, 35294 | |
United States, Florida | |
University of Miami | |
Miami, Florida, United States, 33136 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
Northwestern University-Prentice Hospital | |
Chicago, Illinois, United States, 60611 | |
United States, Michigan | |
Dept of OB/GYN, Hutzel Hospital | |
Detroit, Michigan, United States, 48201 | |
United States, New York | |
Columbia University | |
New York City, New York, United States, 10032 | |
United States, North Carolina | |
Forsyth Memorial Hospital, Wake Forest University School of Medicine | |
Winston-Salem, North Carolina, United States, 27103 | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Ohio | |
Dept of OB/GYN, Ohio State University | |
Columbus, Ohio, United States, 43210 | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267 | |
Case Western Reserve-Metrohealth | |
Cleveland, Ohio, United States, 44109 | |
United States, Pennsylvania | |
Dept of OB/GYN, Magee-Womens Hospital | |
Pittsburgh, Pennsylvania, United States, 15213 | |
MCP Hahnamann | |
Philadelphia, Pennsylvania, United States, 19102 | |
United States, Rhode Island | |
Brown University -Women and Infants Hospital | |
Providence, Rhode Island, United States, 02095 | |
United States, Tennessee | |
University of Tennessee | |
Memphis, Tennessee, United States, 38103 | |
United States, Texas | |
Dept of OB/GYN, Southwestern Medical Center, University of Texas | |
Dallas, Texas, United States, 75235-9032 | |
University of Texas - San Antonio | |
San Antonio, Texas, United States, 78284 | |
University of Texas-Houston | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
University of Utah Medical Center | |
Salt Lake City, Utah, United States, 84132 |
Principal Investigator: | Ronald J Wapner, MD | MCP Hahnemann University Hospital |
Responsible Party: | Pregnancy and Perinatology Branch, NICHD, NIH ( Catherine Y Spong, MD, Chief ) |
Study ID Numbers: | NICHD-0801, HD21410, HD27869, HD27917, HD27860, HD27915, HD34116, HD34208, HD34136, HD40500, HD40485, HD40544, HD40545, HD40560, HD40512, HD36801 |
Study First Received: | April 17, 2001 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00015002 |
Health Authority: | United States: Federal Government |
Antenatal corticosteroids Preterm delivery |
Betamethasone-17,21-dipropionate Sodium phosphate Pregnancy Complications |
Betamethasone sodium phosphate Betamethasone Premature Birth |
Anti-Inflammatory Agents Respiratory System Agents Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Anti-Asthmatic Agents Hormones Glucocorticoids Pharmacologic Actions |