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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

Tracking Information
First Submitted Date  ICMJE April 17, 2001
First Posted Date  ICMJE April 18, 2001
Last Update Posted Date October 3, 2016
Study Start Date  ICMJE March 2000
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Neonatal morbidity
  • Maternal morbidity
  • Neonatal Growth parameters
  • Infant neurological parameters
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repeat Antenatal Steroids Trial
Official Title  ICMJE A Randomized Placebo-Controlled Trial of Antenatal Corticosteroid Regimens
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Complications, Pregnancy
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 27, 2008)
486
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
2400
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00015002
Other Study ID Numbers  ICMJE NICHD-0801
HD21410
HD27869
HD27917
HD27860
HD27915
HD34116
HD34208
HD34136
HD40500
HD40485
HD40544
HD40545
HD40560
HD40512
HD36801
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Responsible Party The George Washington University Biostatistics Center
Study Sponsor  ICMJE The George Washington University Biostatistics Center
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Ronald J Wapner, MD MCP Hahnemann University Hospital
PRS Account The George Washington University Biostatistics Center
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP