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Repeat Antenatal Steroids Trial (BEARS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00015002
Recruitment Status : Terminated (Concerns regarding neonatal data)
First Posted : April 18, 2001
Last Update Posted : October 3, 2016
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2000
Actual Primary Completion Date : May 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine



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.


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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015002


Locations
Show Show 19 study locations
Sponsors and Collaborators
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Ronald J Wapner, MD MCP Hahnemann University Hospital
Additional Information:
Publications of Results:

Other Publications:
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).

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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: April 18, 2001    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be shared after completion and publication of the main analyses in accordance with NIH policy. The dataset can be obtained by emailing mfmudatasets@bsc.gwu.edu
Keywords provided by The George Washington University Biostatistics Center:
Antenatal corticosteroids
Preterm delivery
Additional relevant MeSH terms:
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Pregnancy Complications
Betamethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents