Abstract | OBJECTIVE: METHODS: In a multicenter open-label randomized controlled trial, a cervical pessary was compared with no intervention (control group) (one-to-one ratio). Women between 24 and 34 weeks of gestation at high risk for preterm birth based on a short cervical length (less than 15 mm) or an intermediate cervical length (between 15 and 30 mm) with a positive fetal fibronectin test who did not deliver after an episode of threatened preterm labor were eligible. The primary outcome was birth before 37 weeks of gestation. Secondary outcomes were a composite adverse neonatal outcome, preterm birth before 34 and 32 weeks of gestation, and side effects. A total sample size of 200 women carrying singletons was planned so as to have adequate statistical power to detect a reduction in the rate of preterm birth from 40% to 20%. Women with twin gestations were also enrolled but were considered only in secondary analyses. After a planned interim analysis, the trial was stopped for futility. RESULTS: From November 2013 through September 2016, 130 women with a singleton pregnancy (65 pessary, 65 no treatment) were recruited. The groups had comparable baseline characteristics. In the cervical pessary group, 31 (48%) women delivered before 37 weeks of gestation compared with 25 (39%) in the no-treatment group (relative risk 1.2, 95% CI 0.83-1.8). Nine (15%) children in the cervical pessary group had the composite adverse perinatal outcome compared with eight (13%) in the control group (relative risk 1.2, 95% CI 0.49-2.9). CONCLUSION: CLINICAL TRIAL REGISTRATION: Netherlands Trial Register, NTR4210.
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Authors | Frederik J R Hermans, Ewoud Schuit, Mireille N Bekker, Mallory Woiski, Marjon A de Boer, Marieke Sueters, Hubertina C J Scheepers, Maureen T M Franssen, Eva Pajkrt, Ben Willem J Mol, Marjolein Kok |
Journal | Obstetrics and gynecology
(Obstet Gynecol)
Vol. 132
Issue 3
Pg. 741-749
(09 2018)
ISSN: 1873-233X [Electronic] United States |
PMID | 30095769
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Topics |
- Adult
- Female
- Humans
- Obstetric Labor, Premature
(prevention & control)
- Pessaries
(statistics & numerical data)
- Pregnancy
- Secondary Prevention
- Young Adult
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