Repeat Antenatal Steroids Trial

NCT00015002 | Terminated Phase 3 DMC

• 16 other identifiers: NICHD-0801HD21410HD27869HD27917HD27860HD27915HD34116HD34208HD34136HD40500HD40485HD40544HD40545HD40560HD40512HD36801
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 19

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.

Conditions

Complications, Pregnancy

Keywords

Antenatal corticosteroids; Preterm delivery

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• Neonatal morbidity

• Maternal morbidity

• Neonatal Growth parameters

• Infant neurological parameters

Interventions

Betamethasone DRUG

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (19)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Northwestern University-Prentice Hospital

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Dept of OB/GYN, Hutzel Hospital

Detroit, Michigan, 48201, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Forsyth Memorial Hospital, Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27103, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve-Metrohealth

Cleveland, Ohio, 44109, United States

Location

Dept of OB/GYN, Ohio State University

Columbus, Ohio, 43210, United States

Location

MCP Hahnamann

Philadelphia, Pennsylvania, 19102, United States

Location

Dept of OB/GYN, Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Brown University -Women and Infants Hospital

Providence, Rhode Island, 02095, United States

Location

University of Tennessee

Memphis, Tennessee, 38103, United States

Location

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

Dallas, Texas, 75235-9032, United States

Location

University of Texas-Houston

Houston, Texas, 77030, United States

Location

University of Texas - San Antonio

San Antonio, Texas, 78284, United States

Location

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (12)

• 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.

  PMID: 4561295 BACKGROUND

• 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.

  PMID: 7631713 BACKGROUND

• 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.

  PMID: 9914589 BACKGROUND

• 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.

  PMID: 7823388 BACKGROUND

• 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.

  PMID: 2665800 BACKGROUND

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

  PMID: 7025638 BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 16846587 RESULT

• 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.

  PMID: 18515519 RESULT

• 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.

  PMID: 19546756 RESULT

• 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.

  PMID: 17826421 RESULT

• 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.

  PMID: 17881751 RESULT

Related Links

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

MeSH Terms

Conditions

Pregnancy Complications; Premature Birth

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ronald J Wapner, MD

  MCP Hahnemann University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2001
• First Posted: April 18, 2001
• Study Start: March 1, 2000
• Primary Completion: May 1, 2006
• Study Completion: March 1, 2007
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (19)