Elsevier

The Lancet

Volume 379, Issue 9828, 12–18 May 2012, Pages 1800-1806
The Lancet

Articles
Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial

https://doi.org/10.1016/S0140-6736(12)60030-0Get rights and content

Summary

Background

Most previous studies of the use of cervical pessaries were either retrospective or case controlled and their results showed that this intervention might be a preventive strategy for women at risk of preterm birth; no randomised controlled trials have been undertaken. We therefore undertook a randomised, controlled trial to investigate whether the insertion of a cervical pessary in women with a short cervix identified by use of routine transvaginal scanning at 20–23 weeks of gestation reduces the rate of early preterm delivery.

Methods

The Pesario Cervical para Evitar Prematuridad (PECEP) trial was undertaken in five hospitals in Spain. Pregnant women (aged 18–43 years) with a cervical length of 25 mm or less were randomly assigned according to a computer-generated allocation sequence by use of central telephone in a 1:1 ratio to the cervical pessary or expectant management (without a cervical pessary) group. Because of the nature of the intervention, this study was not masked. The primary outcome was spontaneous delivery before 34 weeks of gestation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00706264.

Findings

385 pregnant women with a short cervix were assigned to the pessary (n=192) and expectant management groups (n=193), and 190 were analysed in each group. Spontaneous delivery before 34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group (12 [6%] vs 51 [27%], odds ratio 0·18, 95% CI 0·08–0·37; p<0·0001). No serious adverse effects associated with the use of a cervical pessary were reported.

Interpretation

Cervical pessary use could prevent preterm birth in a population of appropriately selected at-risk women previously screened for cervical length assessment at the midtrimester scan.

Funding

Instituto Carlos III.

Introduction

Spontaneous preterm birth, which arises in roughly 5–13% of pregnancies, is the leading cause of perinatal morbidity and mortality.1, 2, 3, 4 However, the rates have not changed much over the past 10 years. Improvements in neonatal care have increased survival rates in very premature infants. Nevertheless, a major reduction in rates of mortality and morbidity in premature babies will only be achieved with increased precision in the identification of women at risk of spontaneous preterm birth and through the development of an effective prevention for this complication.

A strategy for the prevention of spontaneous preterm births in which therapeutic intervention is restricted to women with a previous preterm birth is likely to have a small effect on the overall rate of prematurity since only about 10% of spontaneous preterm births arise in women with such a history.5 Ultrasonographic measurement of cervical length at 20–23 weeks of gestation can increase the identification of women at risk of either singleton or twin pregnancies.6, 7, 8 Asymptomatic women with a short cervical length (≤25 mm) are at increased risk of spontaneous early preterm delivery.

Cervical pessary is a silicone device that has been used in the past 50 years to prevent preterm birth.9 Most of the reported studies were either retrospective or case controlled and the results showed that a cervical pessary can be used as a preventive strategy for patients at risk of preterm birth.10 No randomised controlled trials have been undertaken. We therefore assessed the effect of cervical pessary on the spontaneous early preterm birth rate in asymptomatic women.

Section snippets

Participants and trial design

A prospective, open-label, randomised clinical trial was undertaken in five hospitals in Spain. Pregnant women (aged 18–43 years) with singleton pregnancies who were undergoing routine second trimester ultrasonography at 18–22 weeks of gestation were given the option of transvaginal ultrasonographic measurement of cervical length as a predictor of spontaneous preterm birth.11 Cervical length was measured according to the criteria of the Fetal Medicine Foundation.12 Women with a cervical length

Results

The PECEP trial was undertaken from June, 2007, to June, 2010. During the study period, 18 235 women with singleton pregnancies were invited to have transvaginal ultrasonographic measurement of cervical length during the second trimester scan; 11 875 provided written informed consent (figure 4). Median cervical length was 34 mm (range 3–68) and 25 mm or less in 726 (6%) women. 385 (53%) women with a short cervix agreed to participate in the trial. They were randomly assigned to the pessary or

Discussion

The rate of spontaneous birth before 34 weeks of gestation was lower in the pessary group. So far, this study is the first multicentre, randomised trial of the use of a cervical pessary for prevention of preterm birth. However, the potential benefits of this device have been tested successfully in the past—Arabin and colleagues16 reported a preterm birth rate before 34 weeks of zero when they inserted pessaries into women with short cervical lengths at 22 weeks compared with nearly 50% in a

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