17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm

William A. Grobman, Elizabeth A. Thom, Catherine Y. Spong, Jay D. Iams, George Saade, Brian M. Mercer, Alan T N Tita, Dwight J. Rouse, Yoram Sorokin, Ronald J. Wapner, Kenneth J. Leveno, Sean Blackwell, M. Sean Esplin, Jorge E. Tolosa, John M. Thorp, Steve N. Caritis, J. Peter Van Dorsten

Research output: Contribution to journalArticle

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Abstract

Objective: We sought to evaluate whether 17 alpha-hydroxyprogesterone caproate (17-OHP) reduces preterm birth (PTB) in nulliparous women with a midtrimester cervical length (CL) <30 mm. Study Design: In this multicenter randomized controlled trial, nulliparous women with a singleton gestation between 16 and 22 3/7 weeks with an endovaginal CL <30 mm (<10th percentile in this population) were randomized to weekly intramuscular 17-OHP (250 mg) or placebo through 36 weeks. The primary outcome was PTB <37 weeks. Results: The frequency of PTB did not differ between the 17-OHP (n = 327) and placebo (n = 330) groups (25.1% vs 24.2%; relative risk, 1.03; 95% confidence interval, 0.79-1.35). There also was no difference in the composite adverse neonatal outcome (7.0% vs 9.1%; relative risk, 0.77; 95% confidence interval, 0.46-1.30). Conclusion: Weekly 17-OHP does not reduce the frequency of PTB in nulliparous women with a midtrimester CL <30 mm.

Original languageEnglish (US)
JournalAmerican Journal of Obstetrics and Gynecology
Volume207
Issue number5
DOIs
StatePublished - Nov 2012

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Premature Birth
Second Pregnancy Trimester
Placebos
Confidence Intervals
Randomized Controlled Trials
Pregnancy
17-alpha-hydroxy-progesterone caproate
Population

Keywords

  • nulliparous
  • progesterone
  • progestogen
  • short cervix

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm. / Grobman, William A.; Thom, Elizabeth A.; Spong, Catherine Y.; Iams, Jay D.; Saade, George; Mercer, Brian M.; Tita, Alan T N; Rouse, Dwight J.; Sorokin, Yoram; Wapner, Ronald J.; Leveno, Kenneth J.; Blackwell, Sean; Esplin, M. Sean; Tolosa, Jorge E.; Thorp, John M.; Caritis, Steve N.; Van Dorsten, J. Peter.

In: American Journal of Obstetrics and Gynecology, Vol. 207, No. 5, 11.2012.

Research output: Contribution to journalArticle

Grobman, WA, Thom, EA, Spong, CY, Iams, JD, Saade, G, Mercer, BM, Tita, ATN, Rouse, DJ, Sorokin, Y, Wapner, RJ, Leveno, KJ, Blackwell, S, Esplin, MS, Tolosa, JE, Thorp, JM, Caritis, SN & Van Dorsten, JP 2012, '17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm', American Journal of Obstetrics and Gynecology, vol. 207, no. 5. https://doi.org/10.1016/j.ajog.2012.09.013
Grobman, William A. ; Thom, Elizabeth A. ; Spong, Catherine Y. ; Iams, Jay D. ; Saade, George ; Mercer, Brian M. ; Tita, Alan T N ; Rouse, Dwight J. ; Sorokin, Yoram ; Wapner, Ronald J. ; Leveno, Kenneth J. ; Blackwell, Sean ; Esplin, M. Sean ; Tolosa, Jorge E. ; Thorp, John M. ; Caritis, Steve N. ; Van Dorsten, J. Peter. / 17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm. In: American Journal of Obstetrics and Gynecology. 2012 ; Vol. 207, No. 5.
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abstract = "Objective: We sought to evaluate whether 17 alpha-hydroxyprogesterone caproate (17-OHP) reduces preterm birth (PTB) in nulliparous women with a midtrimester cervical length (CL) <30 mm. Study Design: In this multicenter randomized controlled trial, nulliparous women with a singleton gestation between 16 and 22 3/7 weeks with an endovaginal CL <30 mm (<10th percentile in this population) were randomized to weekly intramuscular 17-OHP (250 mg) or placebo through 36 weeks. The primary outcome was PTB <37 weeks. Results: The frequency of PTB did not differ between the 17-OHP (n = 327) and placebo (n = 330) groups (25.1{\%} vs 24.2{\%}; relative risk, 1.03; 95{\%} confidence interval, 0.79-1.35). There also was no difference in the composite adverse neonatal outcome (7.0{\%} vs 9.1{\%}; relative risk, 0.77; 95{\%} confidence interval, 0.46-1.30). Conclusion: Weekly 17-OHP does not reduce the frequency of PTB in nulliparous women with a midtrimester CL <30 mm.",
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AU - Grobman, William A.

AU - Thom, Elizabeth A.

AU - Spong, Catherine Y.

AU - Iams, Jay D.

AU - Saade, George

AU - Mercer, Brian M.

AU - Tita, Alan T N

AU - Rouse, Dwight J.

AU - Sorokin, Yoram

AU - Wapner, Ronald J.

AU - Leveno, Kenneth J.

AU - Blackwell, Sean

AU - Esplin, M. Sean

AU - Tolosa, Jorge E.

AU - Thorp, John M.

AU - Caritis, Steve N.

AU - Van Dorsten, J. Peter

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