American Journal of Obstetrics and Gynecology
ResearchObstetrics: World prematurity day17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 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.
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What now? A critical evaluation of over 20 years of clinical and research experience with 17-alpha hydroxyprogesterone caproate for recurrent preterm birth prevention
2023, American Journal of Obstetrics and Gynecology MFMRelationship between plasma concentration of 17-hydroxyprogesterone caproate and gestational age at preterm delivery
2023, American Journal of Obstetrics and Gynecology MFMImpact of Maternal-Fetal Medicine Units Network's publications on American College of Obstetricians and Gynecologists guidelines
2022, American Journal of Obstetrics and Gynecology MFMEvaluation of midtrimester cervical length thresholds for the prediction of spontaneous preterm birth
2022, Journal of Gynecology Obstetrics and Human ReproductionCitation 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.
Cervical length distribution and other sonographic ancillary findings of singleton nulliparous patients at midgestation
2021, American Journal of Obstetrics and Gynecology
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.