Repeat Antenatal Steroids Trial

Complications, Pregnancy Clinical Trial

— BEARS  

Official title:

A Randomized Placebo-Controlled Trial of Antenatal Corticosteroid Regimens

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00015002
• Other study ID #: NICHD-0801
• Secondary ID: HD21410HD27869HD
• Status: Terminated
• Phase: Phase 3
• Start date: March 2000
• Est. completion date: March 2007

Study information

• Verified date: March 2022
• Source: The George Washington University Biostatistics Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 486
• Est. completion date: March 2007
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Complications, Pregnancy
• Pregnancy Complications

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Northwestern University-Prentice Hospital	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Case Western Reserve-Metrohealth	Cleveland	Ohio
United States	Dept of OB/GYN, Ohio State University	Columbus	Ohio
United States	Dept of OB/GYN, Southwestern Medical Center, University of Texas	Dallas	Texas
United States	Dept of OB/GYN, Hutzel Hospital	Detroit	Michigan
United States	University of Texas-Houston	Houston	Texas
United States	University of Tennessee	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Columbia University	New York	New York
United States	MCP Hahnamann	Philadelphia	Pennsylvania
United States	Dept of OB/GYN, Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	Brown University -Women and Infants Hospital	Providence	Rhode Island
United States	University of Utah Medical Center	Salt Lake City	Utah
United States	University of Texas - San Antonio	San Antonio	Texas
United States	Forsyth Memorial Hospital, Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (12)

Carroll MA, Vidaeff AC, Mele L, Wapner RJ, Mercer B, Peaceman AM, Sorokin Y, Dudley DJ, Spong CY, Leveno KJ, Harper M, Caritis SN, Miodovnik M, Thorp JM, Moawad A, O'Sullivan MJ, Carpenter MW, Rouse DJ, Sibai B; National Institute of Child Health and Huma — View Citation

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. — View Citation

Effect of antenatal dexamethasone administration on the prevention of respiratory distress syndrome. Am J Obstet Gynecol. 1981 Oct 1;141(3):276-87. — View Citation

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. — View Citation

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; Eunice Kennedy Shriver National Institute of Child Heal — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sawady J, Mercer BM, Wapner RJ, Zhao Y, Sorokin Y, Johnson F, Dudley DJ, Spong CY, Peaceman AM, Leveno KJ, Harper M, Caritis SN, Miodovnik M, Thorp JM, Ramin S, Carpenter MW, Rouse DJ; National Institute of Child Health and Human Development Maternal Feta — View Citation

Wapner RJ, Sorokin Y, Mele L, Johnson F, Dudley DJ, Spong CY, Peaceman AM, Leveno KJ, Malone F, Caritis SN, Mercer B, Harper M, Rouse DJ, Thorp JM, Ramin S, Carpenter MW, Gabbe SG; National Institute of Child Health and Human Development Maternal-Fetal Me — View Citation

Wapner RJ, Sorokin Y, Thom EA, Johnson F, Dudley DJ, Spong CY, Peaceman AM, Leveno KJ, Harper M, Caritis SN, Miodovnik M, Mercer B, Thorp JM, Moawad A, O'Sullivan MJ, Ramin S, Carpenter MW, Rouse DJ, Sibai B, Gabbe SG; National Institute of Child Health a — View Citation

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).

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL
Secondary	Neonatal morbidity
Secondary	Maternal morbidity
Secondary	Neonatal Growth parameters
Secondary	Infant neurological parameters

External Links

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