17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm - 30/10/12

Doi : 10.1016/j.ajog.2012.09.013

William A. Grobman, MD, MBA ^a, Elizabeth A. Thom, PhD ^b, Catherine Y. Spong, MD ^q, Jay D. Iams, MD ^c, George R. Saade, MD ^d, Brian M. Mercer, MD ^e, Alan T.N. Tita, MD ^f, Dwight J. Rouse, MD ^g, Yoram Sorokin, MD ^h, Ronald J. Wapner, MD ⁱ, Kenneth J. Leveno, MD ^j, Sean Blackwell, MD ^k, M. Sean Esplin, MD ^l, Jorge E. Tolosa, MD, MSCE ^m, John M. Thorp, MD ⁿ, Steve N. Caritis, MD ^o, J. Peter Van Dorsten, MD ^p
Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network
^a Northwestern University, Chicago, IL
^b George Washington University Biostatistics Center, Washington, DC
^c Ohio State University, Columbus, OH
^d University of Texas Medical Branch, Galveston, TX
^e Case Western Reserve University–MetroHealth Medical Center, Cleveland, OH
^f University of Alabama at Birmingham, Birmingham, AL
^g Brown University, Providence, RI
^h Wayne State University, Detroit, MI
ⁱ Columbia University, New York, NY
^j University of Texas Southwestern Medical Center, Dallas, TX
^k University of Texas Health Science Center at Houston, Houston, TX
^l University of Utah Health Sciences Center, Salt Lake City, UT
^m Oregon Health and Science University, Portland, OR
ⁿ University of North Carolina at Chapel Hill, Chapel Hill, NC
^o University of Pittsburgh, Pittsburgh, PA
^p Medical University of South Carolina, Charleston, SC
^q Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Bethesda, MD

Résumé

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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Key words : nulliparous, progesterone, progestogen, short cervix

Plan

Materials and Methods

Results

Comment

	The project described was supported by grant numbers HD21410, UL1 RR024153, UL1 TR000005, HD27869, HD27915, HD27917, HD34116, HD34208, 5UL1RR025764, HD36801, HD40500, HD40512, HD40544, M01 RR00080, UL1 RR024989 (National Center for Research Resources [NCRR]), HD40545, HD40560, HD40485, HD53097, and HD53118 from the NICHD.
	www.clinicaltrials.gov number, NCT00439374.
	The authors report no conflict of interest.
	This paper does not necessarily represent the official views of the NCRR, NICHD, or National Institutes of Health.
	Reprints not available from the authors.
	Cite this article as: Grobman WA, Thom EA, Spong CY, et al. 17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm. Am J Obstet Gynecol 2012;207:390.e1-8.
	Other members of the NICHD MFMU Network are listed in the Acknowledgments.

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Vol 207 - N° 5

P. 390.e1-390.e8 - novembre 2012 Retour au numéro

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17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm - 30/10/12

Résumé

Objective

Study Design

Results

Conclusion

Plan

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