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Complications, PregnancyPhase 3BEARSNCT00015002

Repeat Antenatal Steroids Trial

A Phase 3 study testing Betamethasone in people with Complications, Pregnancy, run by The George Washington University Biostatistics Center at 19 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Complications, Pregnancy
What is being tested?
Betamethasone
Type of treatment
Injection or infusion
How many people
486 participants
Where
19 sitesUnited States
Study dates
Mar 2000to Mar 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Diagnosis of fetal lung maturity
  • Chorioamnionitis
  • Non-reassuring fetal testing
  • Known major fetal anomaly
  • Corticosteroid therapy, other than qualifying course
  • Insulin dependent diabetes
Show all 10Show fewer
  • 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • University of Alabama

    Birmingham, Alabama, 35294

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Northwestern University-Prentice Hospital

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Case Western Reserve-Metrohealth

    Cleveland, Ohio, 44109

  • Dept of OB/GYN, Ohio State University

    Columbus, Ohio, 43210

  • Dept of OB/GYN, Southwestern Medical Center, University of Texas

    Dallas, Texas, 75235-9032

  • Dept of OB/GYN, Hutzel Hospital

    Detroit, Michigan, 48201

  • University of Texas-Houston

    Houston, Texas, 77030

  • University of Tennessee

    Memphis, Tennessee, 38103

  • University of Miami

    Miami, Florida, 33136

  • Columbia University

    New York, New York, 10032

  • MCP Hahnamann

    Philadelphia, Pennsylvania, 19102

  • Dept of OB/GYN, Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Brown University -Women and Infants Hospital

    Providence, Rhode Island, 02095

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132

  • University of Texas - San Antonio

    San Antonio, Texas, 78284

  • Forsyth Memorial Hospital, Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized Placebo-Controlled Trial of Antenatal Corticosteroid Regimens

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.

Read the 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.

Being tested
Betamethasone
Keywords
Antenatal corticosteroids, Preterm delivery
Medical subject headings
Pregnancy Complications, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BetamethasoneDrug

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

  1. Neonatal morbidity

  2. Maternal morbidity

  3. Neonatal Growth parameters

  4. Infant neurological parameters

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2001 (estimated)
  2. Study startMar 2000
  3. Primary completionMay 2006
  4. Study completionMar 2007

Why it stopped: Concerns regarding neonatal data

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
486 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00015002
Sponsor's protocol ID
NICHD-0801
Other IDs
HD21410, HD27869, HD27917, HD27860, HD27915, HD34116, HD34208, HD34136
Acronym
BEARS
Status last verified
Mar 2022
First submitted
17 Apr 2001
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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

Publications

  • 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. No abstract available.

    PubMed 4561295

  • 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. doi: 10.1016/0002-9378(95)90222-8. No abstract available.

    PubMed 7631713

  • 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. doi: 10.1016/s0002-9378(99)70160-2.

    PubMed 9914589

  • 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. doi: 10.1001/jama.1995.03520290065031.

    PubMed 7823388

  • 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. doi: 10.1111/j.1471-0528.1989.tb02413.x.

    PubMed 2665800

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

    PubMed 7025638

  • 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).

  • 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 and Human Development Maternal Fetal Medicine Units Network. Single versus weekly courses of antenatal corticosteroids: evaluation of safety and efficacy. Am J Obstet Gynecol. 2006 Sep;195(3):633-42. doi: 10.1016/j.ajog.2006.03.087. Epub 2006 Jul 17.

    PubMed 16846587

  • 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 Human Development (NICHD) Maternal Fetal Medicine Units Network (MFMU). Bone metabolism in pregnant women exposed to single compared with multiple courses of corticosteroids. Obstet Gynecol. 2008 Jun;111(6):1352-8. doi: 10.1097/AOG.0b013e318173573b.

    PubMed 18515519

  • 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 Health and Human Development (NICHD) Maternal Fetal Medicine Units Network (MFMU). Bone metabolism in fetuses of pregnant women exposed to single and multiple courses of corticosteroids. Obstet Gynecol. 2009 Jul;114(1):38-44. doi: 10.1097/AOG.0b013e3181a82b85.

    PubMed 19546756

  • 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 Fetal Medicine Units Network. The National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network Beneficial Effects of Antenatal Repeated Steroids study: impact of repeated doses of antenatal corticosteroids on placental growth and histologic findings. Am J Obstet Gynecol. 2007 Sep;197(3):281.e1-8. doi: 10.1016/j.ajog.2007.06.041.

    PubMed 17826421

  • 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 Medicine Units Network. Long-term outcomes after repeat doses of antenatal corticosteroids. N Engl J Med. 2007 Sep 20;357(12):1190-8. doi: 10.1056/NEJMoa071453.

    PubMed 17881751

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Betamethasone in people with Complications, Pregnancy, run by The George Washington University Biostatistics Center at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Concerns regarding neonatal data). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00015002, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022; AzTrials last refreshed its copy on 29 Oct 2026.

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