Cervical cerclage vs cervical pessary in women with cervical insufficiency: A multicentric, open-label, randomised, controlled pilot trial [the CEPEIC trial]

Abstract

Objective Cervical insufficiency accounts for 8 % of preterm births. Pessary and cerclage are considered preventive approaches for preterm birth. These interventions were compared in terms of reducing the prematurity rate in women with previous preterm birth, due to cervical insufficiency or due to having a short cervix in their current pregnancy. Methods This was a prospective, multicentric, open-label, randomised, pilot, controlled trial. Participants were women with singleton pregnancies who had previous preterm birth caused by cervical insufficiency or previous preterm birth and a short cervix [≤ 25 mm] in their current pregnancy. Women were randomised [1:1] to either cerclage or pessary. The primary outcome was to assess the feasibility of a trial on cervical pessary vs. cerclage to prevent preterm birth before 34 weeks in women with cervical insufficiency. As a secondary outcome, we studied the morbidity rate of the pessary versus the cerclage in women with cervical insufficiency and assessed the financial impact of using both devices in these women. The sample size was calculated based on the estimated population that we could potentially recruit: 60 women, 30 for each group, to ascertain whether the rate of preterm birth < 34 weeks of gestation may be reduced from 34 % to at least 27 % in the pessary group, as in the results obtained with the cerclage. Results No significant differences in preterm birth < 34 weeks of gestation were observed in our study, although it was underpowered to detect these differences [the relative risk [RR] of PB < 34 weeks of gestation was 0.8 [95 % CI: 0.31–2.09, p = 0.888]. The rates of obstetric and perinatal complications were similar for both devices [15 cases in both groups, 50 % of cases [RR; 0.6–1.68; p = 1]. Cervical pessary had fewer secondary effects than the cerclage [less bleeding at insertion in the pessary group compared with cerclage, 1 case vs 14 cases, p < 0.001; less pain at removal in the pessary group compared with cerclage, 14 vs 22 cases. p = 0.042 and less bleeding, 2 cases vs. 10 cases, p = 0.027]. Conclusions Pessary does not seem less effective than cerclage, although these findings need to be confirmed in a larger randomised controlled trial. Pessary had fewer secondary effects than cerclage both at insertion and removal. Sinopsis Cervical pessary does not seem to be less effective than cerclage. Cervical pessary had fewer secondary effects than cerclage.