Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate: A randomized controlled trial

Steve N. Caritis, Dwight J. Rouse, Alan M. Peaceman, Anthony Sciscione, Valerija Momirova, Catherine Y. Spong, Jay D. Iams, Ronald J. Wapner, Michael Varner, Marshall Carpenter, Julie Lo, John Thorp, Brian M. Mercer, Yoram Sorokin, Margaret Harper, Susan Ramin, Garland Anderson

Research output: Contribution to journalArticle

91 Citations (Scopus)

Abstract

OBJECTIVE:: To assess whether 17 alpha-hydroxyprogesterone caproate reduces the rate of preterm birth in women carrying triplets. METHODS:: We performed this randomized, double-blinded, placebo-controlled trial in 14 centers. Healthy women with triplets were randomly assigned to weekly intramuscular injections of either 250 mg of 17 alpha-hydroxyprogesterone caproate or matching placebo, starting at 16-20 weeks and ending at delivery or 35 weeks of gestation. The primary study outcome was delivery or fetal loss before 35 weeks. RESULTS:: One hundred thirty-four women were assigned, 71 to 17 alpha-hydroxyprogesterone caproate and 63 to placebo; none were lost to follow-up. Baseline demographic data were similar in the two groups. The proportion of women experiencing the primary outcome (a composite of delivery or fetal loss before 35 0/7 weeks) was similar in the two treatment groups: 83% of pregnancies in the 17 alpha-hydroxyprogesterone caproate group and 84% in the placebo group, relative risk 1.0, 95% confidence interval 0.9-1.1. The lack of benefit of 17 alpha-hydroxyprogesterone caproate was evident regardless of the conception method or whether a gestational age cutoff for delivery was set at 32 or 28 weeks. CONCLUSION:: Treatment with 17 alpha-hydroxyprogesterone caproate did not reduce the rate of preterm birth in women with triplet gestations.

Original languageEnglish (US)
Pages (from-to)285-292
Number of pages8
JournalObstetrics and Gynecology
Volume113
Issue number2 PART 1
DOIs
StatePublished - Feb 2009

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Premature Birth
Randomized Controlled Trials
Placebos
Pregnancy
Lost to Follow-Up
Intramuscular Injections
Gestational Age
17-alpha-hydroxy-progesterone caproate
Demography
Outcome Assessment (Health Care)
Confidence Intervals
Therapeutics

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Caritis, S. N., Rouse, D. J., Peaceman, A. M., Sciscione, A., Momirova, V., Spong, C. Y., ... Anderson, G. (2009). Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate: A randomized controlled trial. Obstetrics and Gynecology, 113(2 PART 1), 285-292. https://doi.org/10.1097/AOG.0b013e318193c677

Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate : A randomized controlled trial. / Caritis, Steve N.; Rouse, Dwight J.; Peaceman, Alan M.; Sciscione, Anthony; Momirova, Valerija; Spong, Catherine Y.; Iams, Jay D.; Wapner, Ronald J.; Varner, Michael; Carpenter, Marshall; Lo, Julie; Thorp, John; Mercer, Brian M.; Sorokin, Yoram; Harper, Margaret; Ramin, Susan; Anderson, Garland.

In: Obstetrics and Gynecology, Vol. 113, No. 2 PART 1, 02.2009, p. 285-292.

Research output: Contribution to journalArticle

Caritis, SN, Rouse, DJ, Peaceman, AM, Sciscione, A, Momirova, V, Spong, CY, Iams, JD, Wapner, RJ, Varner, M, Carpenter, M, Lo, J, Thorp, J, Mercer, BM, Sorokin, Y, Harper, M, Ramin, S & Anderson, G 2009, 'Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate: A randomized controlled trial', Obstetrics and Gynecology, vol. 113, no. 2 PART 1, pp. 285-292. https://doi.org/10.1097/AOG.0b013e318193c677
Caritis, Steve N. ; Rouse, Dwight J. ; Peaceman, Alan M. ; Sciscione, Anthony ; Momirova, Valerija ; Spong, Catherine Y. ; Iams, Jay D. ; Wapner, Ronald J. ; Varner, Michael ; Carpenter, Marshall ; Lo, Julie ; Thorp, John ; Mercer, Brian M. ; Sorokin, Yoram ; Harper, Margaret ; Ramin, Susan ; Anderson, Garland. / Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate : A randomized controlled trial. In: Obstetrics and Gynecology. 2009 ; Vol. 113, No. 2 PART 1. pp. 285-292.
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AU - Sciscione, Anthony

AU - Momirova, Valerija

AU - Spong, Catherine Y.

AU - Iams, Jay D.

AU - Wapner, Ronald J.

AU - Varner, Michael

AU - Carpenter, Marshall

AU - Lo, Julie

AU - Thorp, John

AU - Mercer, Brian M.

AU - Sorokin, Yoram

AU - Harper, Margaret

AU - Ramin, Susan

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N2 - OBJECTIVE:: To assess whether 17 alpha-hydroxyprogesterone caproate reduces the rate of preterm birth in women carrying triplets. METHODS:: We performed this randomized, double-blinded, placebo-controlled trial in 14 centers. Healthy women with triplets were randomly assigned to weekly intramuscular injections of either 250 mg of 17 alpha-hydroxyprogesterone caproate or matching placebo, starting at 16-20 weeks and ending at delivery or 35 weeks of gestation. The primary study outcome was delivery or fetal loss before 35 weeks. RESULTS:: One hundred thirty-four women were assigned, 71 to 17 alpha-hydroxyprogesterone caproate and 63 to placebo; none were lost to follow-up. Baseline demographic data were similar in the two groups. The proportion of women experiencing the primary outcome (a composite of delivery or fetal loss before 35 0/7 weeks) was similar in the two treatment groups: 83% of pregnancies in the 17 alpha-hydroxyprogesterone caproate group and 84% in the placebo group, relative risk 1.0, 95% confidence interval 0.9-1.1. The lack of benefit of 17 alpha-hydroxyprogesterone caproate was evident regardless of the conception method or whether a gestational age cutoff for delivery was set at 32 or 28 weeks. CONCLUSION:: Treatment with 17 alpha-hydroxyprogesterone caproate did not reduce the rate of preterm birth in women with triplet gestations.

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