Research
Obstetrics: World prematurity day
17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm

Presented at the 32nd annual meeting of the Society for Maternal-Fetal Medicine, Dallas, TX, Feb. 6-11, 2012.
https://doi.org/10.1016/j.ajog.2012.09.013Get rights and content

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.

Section snippets

Materials and Methods

From April 2007 through May 2011, the 14 centers of the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development participated in this randomized double-blind placebo-controlled trial. The study was approved by the institutional review board at each clinical site and at the data coordinating center.

Women were eligible for participation if they were nulliparous with a viable singleton gestation and had a CL <30 mm between 16

Results

A total of 15,435 women were screened, of whom 1588 (10.3%) had a CL <30 mm. At the time the study was halted, 657 women had been randomized. Outcome data were available for all randomized participants and their neonates (Figure 1). Baseline characteristics of the 2 study groups were largely similar, although women randomized to 17-OHP treatment were slightly older (Table 1). The mean compliance rate was 88.8% in the 17-OHP group and 89.1% in the placebo group (P = .89). Seven women (1.1%) also

Comment

In this randomized trial conducted among nulliparous women with singleton gestations and midtrimester CLs <30 mm, weekly IM injections of 250 mg 17-OHP neither altered the frequency of PTB <37 weeks nor had a discernable effect on PTB at lower gestational age thresholds, maternal outcomes, or most neonatal complications. While there was a lower frequency of early-onset sepsis among the neonates of mothers exposed to 17-OHP, the lack of difference between the 2 groups in either gestational age

Acknowledgments

We thank the following subcommittee members who participated in protocol/data management and statistical analysis (Sharon Gilbert, MS, MBA) and protocol development and coordination between clinical research centers (Gail Mallett, RN, BSN, CCRC, and Cynthia Milluzzi, RN).

In addition to the authors, other members of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network are as follows:

  • Northwestern University, Chicago, IL–A.

References (23)

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    Prediction and prevention of recurrent spontaneous preterm birth

    Obstet Gynecol

    (2007)
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    • Evaluation of midtrimester cervical length thresholds for the prediction of spontaneous preterm birth

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      Citation Excerpt :

      However, no large randomized trial has yet specifically examined such benefits in women with mid-trimester CL greater than 25 mm. Grobman et al. performed a randomized trial to estimate the effect of weekly intramuscular 17 alpha-hydroxyprogesterone caproate (17-OHP) on the rate of PTB in women with a midtrimester CL less than 30 mm (10th centile) [22]. They observed no significant benefit of 17-OHP, but they reported high rates of PTB (25%) and adverse neonatal outcomes (8%) in this population.

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    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.

    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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