Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate

Paul J. Meis*, Mark Klebanoff, Elizabeth Thom, Mitchell P. Dombrowski, Baha Sibai, Atef H. Moawad, Catherine Y. Spong, John C. Hauth, Menachem Miodovnik, Michael W. Varner, Kenneth J. Leveno, Steve N. Caritis, Jay D. Iams, Ronald J. Wapner, Deborah Conway, Mary J. O'Sullivan, Marshall Carpenter, Brian Mercer, Susan M. Ramin, John M. Thorp & 1 others Alan M Peaceman

*Corresponding author for this work

Research output: Contribution to journalArticle

1055 Citations (Scopus)

Abstract

BACKGROUND: Women who have had a spontaneous preterm delivery are at greatly increased risk for preterm delivery in subsequent pregnancies. The results of several small trials have suggested that 17 alpha-hydroxyprogesterone caproate (17P) may reduce the risk of preterm delivery. METHODS: We conducted a double-blind, placebo-controlled trial involving pregnant women with a documented history of spontaneous preterm delivery. Women were enrolled at 19 clinical centers at 16 to 20 weeks of gestation and randomly assigned by a central data center, in a 2:1 ratio, to receive either weekly injections of 250 mg of 17P or weekly injections of an inert oil placebo; injections were continued until delivery or to 36 weeks of gestation. The primary outcome was preterm delivery before 37 weeks of gestation. Analysis was performed according to the intention-to-treat principle. RESULTS: Base-line characteristics of the 310 women in the progesterone group and the 153 women in the placebo group were similar. Treatment with 17P significantly reduced the risk of delivery at less than 37 weeks of gestation (incidence, 36.3 percent in the progesterone group vs. 54.9 percent in the placebo group; relative risk, 0.66 [95 percent confidence interval, 0.54 to 0.81]), delivery at less than 35 weeks of gestation (incidence, 20.6 percent vs. 30.7 percent; relative risk, 0.67 [95 percent confidence interval, 0.48 to 0.93]), and delivery at less than 32 weeks of gestation (11.4 percent vs. 19.6 percent; relative risk, 0.58 [95 percent confidence interval, 0.37 to 0.91]). Infants of women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen. CONCLUSIONS: Weekly injections of 17P resulted in a substantial reduction in the rate of recurrent preterm delivery among women who were at particularly high risk for preterm delivery and reduced the likelihood of several complications in their infants.

Original languageEnglish (US)
Pages (from-to)2379-2385
Number of pages7
JournalNew England Journal of Medicine
Volume348
Issue number24
DOIs
StatePublished - Jun 12 2003

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Pregnancy
Placebos
Injections
Confidence Intervals
Progesterone
Necrotizing Enterocolitis
Incidence
17-alpha-hydroxy-progesterone caproate
Pregnant Women
Oils
Hemorrhage
Oxygen
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Meis, P. J., Klebanoff, M., Thom, E., Dombrowski, M. P., Sibai, B., Moawad, A. H., ... Peaceman, A. M. (2003). Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. New England Journal of Medicine, 348(24), 2379-2385. https://doi.org/10.1056/NEJMoa035140
Meis, Paul J. ; Klebanoff, Mark ; Thom, Elizabeth ; Dombrowski, Mitchell P. ; Sibai, Baha ; Moawad, Atef H. ; Spong, Catherine Y. ; Hauth, John C. ; Miodovnik, Menachem ; Varner, Michael W. ; Leveno, Kenneth J. ; Caritis, Steve N. ; Iams, Jay D. ; Wapner, Ronald J. ; Conway, Deborah ; O'Sullivan, Mary J. ; Carpenter, Marshall ; Mercer, Brian ; Ramin, Susan M. ; Thorp, John M. ; Peaceman, Alan M. / Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. In: New England Journal of Medicine. 2003 ; Vol. 348, No. 24. pp. 2379-2385.
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abstract = "BACKGROUND: Women who have had a spontaneous preterm delivery are at greatly increased risk for preterm delivery in subsequent pregnancies. The results of several small trials have suggested that 17 alpha-hydroxyprogesterone caproate (17P) may reduce the risk of preterm delivery. METHODS: We conducted a double-blind, placebo-controlled trial involving pregnant women with a documented history of spontaneous preterm delivery. Women were enrolled at 19 clinical centers at 16 to 20 weeks of gestation and randomly assigned by a central data center, in a 2:1 ratio, to receive either weekly injections of 250 mg of 17P or weekly injections of an inert oil placebo; injections were continued until delivery or to 36 weeks of gestation. The primary outcome was preterm delivery before 37 weeks of gestation. Analysis was performed according to the intention-to-treat principle. RESULTS: Base-line characteristics of the 310 women in the progesterone group and the 153 women in the placebo group were similar. Treatment with 17P significantly reduced the risk of delivery at less than 37 weeks of gestation (incidence, 36.3 percent in the progesterone group vs. 54.9 percent in the placebo group; relative risk, 0.66 [95 percent confidence interval, 0.54 to 0.81]), delivery at less than 35 weeks of gestation (incidence, 20.6 percent vs. 30.7 percent; relative risk, 0.67 [95 percent confidence interval, 0.48 to 0.93]), and delivery at less than 32 weeks of gestation (11.4 percent vs. 19.6 percent; relative risk, 0.58 [95 percent confidence interval, 0.37 to 0.91]). Infants of women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen. CONCLUSIONS: Weekly injections of 17P resulted in a substantial reduction in the rate of recurrent preterm delivery among women who were at particularly high risk for preterm delivery and reduced the likelihood of several complications in their infants.",
author = "Meis, {Paul J.} and Mark Klebanoff and Elizabeth Thom and Dombrowski, {Mitchell P.} and Baha Sibai and Moawad, {Atef H.} and Spong, {Catherine Y.} and Hauth, {John C.} and Menachem Miodovnik and Varner, {Michael W.} and Leveno, {Kenneth J.} and Caritis, {Steve N.} and Iams, {Jay D.} and Wapner, {Ronald J.} and Deborah Conway and O'Sullivan, {Mary J.} and Marshall Carpenter and Brian Mercer and Ramin, {Susan M.} and Thorp, {John M.} and Peaceman, {Alan M}",
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Meis, PJ, Klebanoff, M, Thom, E, Dombrowski, MP, Sibai, B, Moawad, AH, Spong, CY, Hauth, JC, Miodovnik, M, Varner, MW, Leveno, KJ, Caritis, SN, Iams, JD, Wapner, RJ, Conway, D, O'Sullivan, MJ, Carpenter, M, Mercer, B, Ramin, SM, Thorp, JM & Peaceman, AM 2003, 'Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate', New England Journal of Medicine, vol. 348, no. 24, pp. 2379-2385. https://doi.org/10.1056/NEJMoa035140

Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. / Meis, Paul J.; Klebanoff, Mark; Thom, Elizabeth; Dombrowski, Mitchell P.; Sibai, Baha; Moawad, Atef H.; Spong, Catherine Y.; Hauth, John C.; Miodovnik, Menachem; Varner, Michael W.; Leveno, Kenneth J.; Caritis, Steve N.; Iams, Jay D.; Wapner, Ronald J.; Conway, Deborah; O'Sullivan, Mary J.; Carpenter, Marshall; Mercer, Brian; Ramin, Susan M.; Thorp, John M.; Peaceman, Alan M.

In: New England Journal of Medicine, Vol. 348, No. 24, 12.06.2003, p. 2379-2385.

Research output: Contribution to journalArticle

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T1 - Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate

AU - Meis, Paul J.

AU - Klebanoff, Mark

AU - Thom, Elizabeth

AU - Dombrowski, Mitchell P.

AU - Sibai, Baha

AU - Moawad, Atef H.

AU - Spong, Catherine Y.

AU - Hauth, John C.

AU - Miodovnik, Menachem

AU - Varner, Michael W.

AU - Leveno, Kenneth J.

AU - Caritis, Steve N.

AU - Iams, Jay D.

AU - Wapner, Ronald J.

AU - Conway, Deborah

AU - O'Sullivan, Mary J.

AU - Carpenter, Marshall

AU - Mercer, Brian

AU - Ramin, Susan M.

AU - Thorp, John M.

AU - Peaceman, Alan M

PY - 2003/6/12

Y1 - 2003/6/12

N2 - BACKGROUND: Women who have had a spontaneous preterm delivery are at greatly increased risk for preterm delivery in subsequent pregnancies. The results of several small trials have suggested that 17 alpha-hydroxyprogesterone caproate (17P) may reduce the risk of preterm delivery. METHODS: We conducted a double-blind, placebo-controlled trial involving pregnant women with a documented history of spontaneous preterm delivery. Women were enrolled at 19 clinical centers at 16 to 20 weeks of gestation and randomly assigned by a central data center, in a 2:1 ratio, to receive either weekly injections of 250 mg of 17P or weekly injections of an inert oil placebo; injections were continued until delivery or to 36 weeks of gestation. The primary outcome was preterm delivery before 37 weeks of gestation. Analysis was performed according to the intention-to-treat principle. RESULTS: Base-line characteristics of the 310 women in the progesterone group and the 153 women in the placebo group were similar. Treatment with 17P significantly reduced the risk of delivery at less than 37 weeks of gestation (incidence, 36.3 percent in the progesterone group vs. 54.9 percent in the placebo group; relative risk, 0.66 [95 percent confidence interval, 0.54 to 0.81]), delivery at less than 35 weeks of gestation (incidence, 20.6 percent vs. 30.7 percent; relative risk, 0.67 [95 percent confidence interval, 0.48 to 0.93]), and delivery at less than 32 weeks of gestation (11.4 percent vs. 19.6 percent; relative risk, 0.58 [95 percent confidence interval, 0.37 to 0.91]). Infants of women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen. CONCLUSIONS: Weekly injections of 17P resulted in a substantial reduction in the rate of recurrent preterm delivery among women who were at particularly high risk for preterm delivery and reduced the likelihood of several complications in their infants.

AB - BACKGROUND: Women who have had a spontaneous preterm delivery are at greatly increased risk for preterm delivery in subsequent pregnancies. The results of several small trials have suggested that 17 alpha-hydroxyprogesterone caproate (17P) may reduce the risk of preterm delivery. METHODS: We conducted a double-blind, placebo-controlled trial involving pregnant women with a documented history of spontaneous preterm delivery. Women were enrolled at 19 clinical centers at 16 to 20 weeks of gestation and randomly assigned by a central data center, in a 2:1 ratio, to receive either weekly injections of 250 mg of 17P or weekly injections of an inert oil placebo; injections were continued until delivery or to 36 weeks of gestation. The primary outcome was preterm delivery before 37 weeks of gestation. Analysis was performed according to the intention-to-treat principle. RESULTS: Base-line characteristics of the 310 women in the progesterone group and the 153 women in the placebo group were similar. Treatment with 17P significantly reduced the risk of delivery at less than 37 weeks of gestation (incidence, 36.3 percent in the progesterone group vs. 54.9 percent in the placebo group; relative risk, 0.66 [95 percent confidence interval, 0.54 to 0.81]), delivery at less than 35 weeks of gestation (incidence, 20.6 percent vs. 30.7 percent; relative risk, 0.67 [95 percent confidence interval, 0.48 to 0.93]), and delivery at less than 32 weeks of gestation (11.4 percent vs. 19.6 percent; relative risk, 0.58 [95 percent confidence interval, 0.37 to 0.91]). Infants of women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen. CONCLUSIONS: Weekly injections of 17P resulted in a substantial reduction in the rate of recurrent preterm delivery among women who were at particularly high risk for preterm delivery and reduced the likelihood of several complications in their infants.

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Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. New England Journal of Medicine. 2003 Jun 12;348(24):2379-2385. https://doi.org/10.1056/NEJMoa035140