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Randomized Controlled Trial
. 2017 Dec 19;318(23):2317-2324.
doi: 10.1001/jama.2017.18956.

Effect of Cervical Pessary on Spontaneous Preterm Birth in Women With Singleton Pregnancies and Short Cervical Length: A Randomized Clinical Trial

Gabriele Saccone  1 , Giuseppe Maria Maruotti  1 , Antonia Giudicepietro  1 , Pasquale Martinelli  1 ; Italian Preterm Birth Prevention (IPP) Working Group
Affiliations
Randomized Controlled Trial

Effect of Cervical Pessary on Spontaneous Preterm Birth in Women With Singleton Pregnancies and Short Cervical Length: A Randomized Clinical Trial

Gabriele Saccone et al. JAMA. .

Erratum in

Abstract

Importance: Spontaneous preterm birth is a major cause of perinatal morbidity and mortality. It is unclear if a cervical pessary can reduce the risk of spontaneous preterm delivery.

Objective: To test whether in asymptomatic women with singleton pregnancies and no prior spontaneous preterm birth but with short cervical length on transvaginal ultrasound, use of a cervical pessary would reduce the rate of spontaneous preterm birth at less than 34 weeks of gestation.

Design, setting, and participants: Parallel-group, nonblinded, randomized clinical trial conducted from March 1, 2016, to May 25, 2017, at a single center in Italy. Asymptomatic women with singleton gestations, no previous spontaneous preterm births, and cervical lengths of 25 mm or less at 18 weeks 0 days to 23 weeks 6 days of gestation were eligible.

Interventions: Patients were randomized 1:1 to receive either cervical pessary (n = 150) or no pessary (n = 150). The pessary was removed between 37 weeks 0 days and 37 weeks 6 days of gestation or earlier if clinically indicated. The control group received standard care. For cervical length of 20 mm or shorter, women in both groups were prescribed vaginal progesterone, 200 mg/d, until 36 weeks 6 days of gestation. No bed rest or activity restriction was recommended.

Main outcomes and measures: The primary end point was spontaneous preterm birth at less than 34 weeks of gestation. Secondary outcomes were adverse events.

Results: Among 300 women who were randomized (mean age, 29 [SD, 6.3] years; mean gestational age, 22 [SD, 1.3] weeks), 100% completed the trial. The primary end point occurred in 11 women (7.3%) in the pessary group and 23 women (15.3%) in the control group (between-group difference, -8.0% [95% CI, -15.7% to -0.4]; relative risk, 0.48 [95% CI, 0.24-0.95]). During follow-up, the pessary group had a higher rate of increased or new vaginal discharge (86.7% vs 46.0%; between-group difference, +40.7% [95% CI, +30.1%-+50.3%]; relative risk, 1.88 [95% CI, 1.57-2.27]).

Conclusions and relevance: Among women without prior spontaneous preterm birth who had asymptomatic singleton pregnancies and short transvaginal cervical length, use of a cervical pessary, compared with no pessary use, resulted in a lower rate of spontaneous preterm birth at less than 34 weeks of gestation. The results of this single-center, nonblinded study among selected pregnant women require confirmation in multicenter clinical trials.

Trial registration: clinicaltrials.gov Identifier: NCT02716909.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

Figures

Figure 1.
Figure 1.. Flow of Participants in a Trial of the Effect of Cervical Pessary Use on Spontaneous Preterm Birth in Women With Singleton Pregnancies and Short Cervical Length
TVU indicates transvaginal ultrasound.
Figure 2.
Figure 2.. Kaplan-Meier Plot of the Probability of Continued Pregnancy Without Delivery in the Cervical Pessary and Control Groups
See this image and copyright information in PMC

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