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 R. 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

doi:10.1016/j.ajog.2012.09.013

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 R. 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

Obstetrics & Gynecology

Research output: Contribution to journal › Article › peer-review

107 Scopus citations

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 language	English (US)
Pages (from-to)	390.e1-390.e8
Journal	American journal of obstetrics and gynecology
Volume	207
Issue number	5
DOIs	https://doi.org/10.1016/j.ajog.2012.09.013
State	Published - Nov 2012

Keywords

nulliparous
progesterone
progestogen
short cervix

ASJC Scopus subject areas

Obstetrics and Gynecology

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10.1016/j.ajog.2012.09.013

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Grobman, W. A., Thom, E. A., Spong, C. Y., Iams, J. D., Saade, G. R., Mercer, B. M., Tita, A. T. N., Rouse, D. J., Sorokin, Y., Wapner, R. J., Leveno, K. J., Blackwell, S., Esplin, M. S., Tolosa, J. E., Thorp, J. M., Caritis, S. N., & Van Dorsten, J. P. (2012). 17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm. American journal of obstetrics and gynecology, 207(5), 390.e1-390.e8. https://doi.org/10.1016/j.ajog.2012.09.013

Grobman, WA, Thom, EA, Spong, CY, Iams, JD, Saade, GR, 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, pp. 390.e1-390.e8. https://doi.org/10.1016/j.ajog.2012.09.013

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

year = "2012",

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doi = "10.1016/j.ajog.2012.09.013",

language = "English (US)",

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T1 - 17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm

AU - Grobman, William A.

AU - Thom, Elizabeth A.

AU - Spong, Catherine Y.

AU - Iams, Jay D.

AU - Saade, George R.

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

PY - 2012/11

Y1 - 2012/11

N2 - 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.

AB - 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.

KW - nulliparous

KW - progesterone

KW - progestogen

KW - short cervix

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ER -

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

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