Repeat Antenatal Steroids Trial (BEARS)

This study has been terminated.
(Concerns regarding neonatal data)
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00015002
First received: April 17, 2001
Last updated: January 1, 2010
Last verified: December 2009
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-Controlled Trial of Antenatal Corticosteroid Regimens

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

Secondary Outcome Measures:
  • Neonatal morbidity
  • Maternal morbidity
  • Neonatal Growth parameters
  • Infant neurological parameters

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)
Intervention Details:
    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.
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015002

Locations
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
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Forsyth Memorial Hospital, Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Case Western Reserve-Metrohealth
Cleveland, Ohio, United States, 44109
Dept of OB/GYN, Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
MCP Hahnamann
Philadelphia, Pennsylvania, United States, 19102
Dept of OB/GYN, Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
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-Houston
Houston, Texas, United States, 77030
University of Texas - San Antonio
San Antonio, Texas, United States, 78284
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Investigators
Principal Investigator: Ronald J Wapner, MD MCP Hahnemann University Hospital
  More Information

Additional Information:
Publications:
Carroll MA, Vidaeff AC, Mele L, Wapner RJ, Mercer BM, Peaceman AM, Sorokin Y, Dudley DJ, Spong CY, Leveno KJ, Harper M, Caritis SN, Miodovnik M,Thorp JM, Moawad AH,O'Sullivan MJ, Carpenter MW, Rouse DJ, Sibai BM, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Bone metabolism in pregnant women exposed to single compared with multiple courses of corticosteroids. Obstetrics and Gynecology, 111:1352-1358, 2008.
Fonseca L, Ramin SM, Mele L, Wapner RJ, Johnson F, Peaceman AM, Sorokin Y, Dudley DJ,Spong CY, Leveno KJ, Caritis SN, Miodovnik M, Mercer B, Thorp JM, O'Sullivan MJ,Carpenter MW, Rouse DJ, Sibai B, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Bone metabolism in fetuses of pregnant women exposed to single and multiple courses of corticosteroids. Obstetrics and Gynecology, 114:38-44, 2009.
Wright LL. Evidence from multicenter networks on the current use and effectiveness of antenatal corticosteroids in very low birthweight infants. In: National Institute of Child Health and Development (US). Report on the Consensus Development Conference on the Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes; 1994 Feb 28-Mar 2; Bethesda, (MD): The Institute; 1994 Nov. P. 47-8. (NIH Publication; no. 95-3784).

Responsible Party: Catherine Y Spong, MD, Chief, Pregnancy and Perinatology Branch, NICHD, NIH
ClinicalTrials.gov Identifier: NCT00015002     History of Changes
Other 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: January 1, 2010
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Antenatal corticosteroids
Preterm delivery

Additional relevant MeSH terms:
Pregnancy Complications
Betamethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014