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Randomized Controlled Trial
. 2012 Nov;207(5):390.e1-8.
doi: 10.1016/j.ajog.2012.09.013. Epub 2012 Sep 17.

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

William A Grobman  1 , 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 Jr, Steve N Caritis, J Peter Van Dorsten; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network
Collaborators, Affiliations
Randomized Controlled Trial

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

William A Grobman et al. Am J Obstet Gynecol. 2012 Nov.

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.

Trial registration: ClinicalTrials.gov NCT00439374.

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Conflict of interest statement

DISCLOSURE: The authors report no conflict of interest

Figures

Figure 1
Figure 1
Flow diagram detailing patient enrollment
Figure 2
Figure 2
Survival curve illustrating the proportion of participants remaining pregnant after randomization.
See this image and copyright information in PMC

Comment in

  • Progesterone for preterm labour.
    Thornton J. Thornton J. BJOG. 2016 Nov;123(12):2000. doi: 10.1111/1471-0528.13976. Epub 2016 Mar 30. BJOG. 2016. PMID: 27028883 No abstract available.

References

    1. Spong CY. Prediction and prevention of recurrent spontaneous preterm birth. Obstet Gynecol. 2007;110:405–415. - PubMed
    1. Rogers LK, Velten M. Maternal inflammation, growth retardation, and preterm birth: insights into adult cardiovascular disease. Life Sci. 2011;89:417–421. - PubMed
    1. DaFonseca EB, Bittar RE, Carvalho MHB, Zugaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol. 2003;188:419–424. - PubMed
    1. Meis PJ, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003;348:2379–2385. - PubMed
    1. Petrini JR, Callaghan WM, Klebanoff M, et al. Estimated effect of 17 alphahydroxyprogesterone caproate on preterm birth in the United States. Obstet Gynecol. 2005;105:267–272. - PubMed

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