BEARS: Repeat Antenatal Steroids Trial

• Sponsor: The George Washington University Biostatistics Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00015002
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 486
• Locations: 19
• Duration (Months): 84
• Patients Per Site: 25.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complications, Pregnancy	Drug: Betamethasone	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 486 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Placebo-Controlled Trial of Antenatal Corticosteroid Regimens
• Study Start Date: Mar 1, 2000
• Actual Primary Completion Date: May 1, 2006
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Neonatal morbidity []

2. Maternal morbidity []

3. Neonatal Growth parameters []

4. Infant neurological parameters []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	University of Miami	Miami	Florida	United States	33136
3	Northwestern University-Prentice Hospital	Chicago	Illinois	United States	60611
4	University of Chicago	Chicago	Illinois	United States	60637
5	Dept of OB/GYN, Hutzel Hospital	Detroit	Michigan	United States	48201
6	Columbia University	New York	New York	United States	10032
7	University of North Carolina	Chapel Hill	North Carolina	United States	27599
8	Forsyth Memorial Hospital, Wake Forest University School of Medicine	Winston-Salem	North Carolina	United States	27103
9	University of Cincinnati	Cincinnati	Ohio	United States	45267
10	Case Western Reserve-Metrohealth	Cleveland	Ohio	United States	44109
11	Dept of OB/GYN, Ohio State University	Columbus	Ohio	United States	43210
12	MCP Hahnamann	Philadelphia	Pennsylvania	United States	19102
13	Dept of OB/GYN, Magee-Womens Hospital	Pittsburgh	Pennsylvania	United States	15213
14	Brown University -Women and Infants Hospital	Providence	Rhode Island	United States	02095
15	University of Tennessee	Memphis	Tennessee	United States	38103
16	Dept of OB/GYN, Southwestern Medical Center, University of Texas	Dallas	Texas	United States	75235-9032
17	University of Texas-Houston	Houston	Texas	United States	77030
18	University of Texas - San Antonio	San Antonio	Texas	United States	78284
19	University of Utah Medical Center	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• The George Washington University Biostatistics Center
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here for more information on the NICHD MFMU Research Network.

Publications

• Crowley PA. Antenatal corticosteroid therapy: a meta-analysis of the randomized trials, 1972 to 1994. Am J Obstet Gynecol. 1995 Jul;173(1):322-35.
• Effect of antenatal dexamethasone administration on the prevention of respiratory distress syndrome. Am J Obstet Gynecol. 1981 Oct 1;141(3):276-87.
• Effect of corticosteroids for fetal maturation on perinatal outcomes. NIH Consensus Development Panel on the Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes. JAMA. 1995 Feb 1;273(5):413-8. Review.
• French NP, Hagan R, Evans SF, Godfrey M, Newnham JP. Repeated antenatal corticosteroids: size at birth and subsequent development. Am J Obstet Gynecol. 1999 Jan;180(1 Pt 1):114-21.
• Gamsu HR, Mullinger BM, Donnai P, Dash CH. Antenatal administration of betamethasone to prevent respiratory distress syndrome in preterm infants: report of a UK multicentre trial. Br J Obstet Gynaecol. 1989 Apr;96(4):401-10.
• Liggins GC, Howie RN. A controlled trial of antepartum glucocorticoid treatment for prevention of the respiratory distress syndrome in premature infants. Pediatrics. 1972 Oct;50(4):515-25.
• 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: The George Washington University Biostatistics Center
• ClinicalTrials.gov Identifier: NCT00015002
• Other Study ID Numbers: NICHD-0801; HD21410; HD27869; HD27917; HD27860; HD27915; HD34116; HD34208; HD34136; HD40500; HD40485; HD40544; HD40545; HD40560; HD40512; HD36801
• First Posted: Apr 18, 2001
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by The George Washington University Biostatistics Center: Antenatal corticosteroids; Preterm delivery
• Additional relevant MeSH terms: Pregnancy Complications; Betamethasone

Study Results

No Results Posted as of Mar 31, 2022