Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins)

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• 作者：Maria Goya ; MD ; PhD^a ; ^{mgoya@vhebron.net" class="auth_mail" title="E-mail the corresponding author} ; Maria de la Calle ; MD ; PhD^b ; Laia Pratcorona ; MD^a ; Carme Merced ; MD^a ; Carlota Rodó ; MD^a ; Begoñ ; a Muñ ; oz ; MD ; PhD^c ; Miquel Juan ; MD^d ; Ariana Serrano ; MD^e ; Elisa Llurba ; MD ; PhD^a ; Teresa Higueras ; MD ; PhD^a ; Elena Carreras ; MD ; PhD^a ; Luis Cabero ; MD ; PhD^a ; on behalf of the PECEP-Twins Trial GroupSilvia Arevalo ; Maite Aviles ; Ines Calero ; Manuel Casellas ; Marina Folch ; Itziar Garcí ; a ; Maria A. Sanchez ; Juan Sagalá ; Anna Suy ; Fernando Magdaleno ; Jose Luis Bartha ; Josep R. Pascual ; Montserrat Inglé ; s ; Pere Cavallé ; Carmina Comas
• 关键词：cervical length ; neonatal morbidity and mortality ; prematurity ; preterm birth ; short cervix ; twins
• 刊名：American Journal of Obstetrics and Gynecology
• 出版年：2016
• 出版时间：February 2016
• 年：2016
• 卷：214
• 期：2
• 页码：145-152
• 全文大小：475 K

文摘

Spontaneous preterm birth (SPB) is the leading cause of perinatal morbidity and mortality. In twins, the rate of preterm birth is higher than in singletons; interventions to prevent preterm birth are needed in this high-risk population.

Objective

We sought to test whether a cervical pessary reduces the preterm birth rate in twin pregnancies with sonographic short cervix.

Study Design

A prospective, open-label, multicenter, randomized clinical trial was conducted in 5 hospitals in Spain. The ethics committees of all participating hospitals approved the protocol. The trial was registered as ClinicalTrials.gov, number 2410">NCT01242410. Eligible women were scanned in Spain. The primary outcome was SPB <34 weeks of gestation. Neonatal morbidity and mortality were also evaluated.

Results

Cervical length was measured in 2287 women; 137 pregnant women with a sonographic cervical length ≤25 mm (of 154 detected with a short cervix) were randomly assigned to receive a cervical pessary or expectant management (1:1 ratio). SPB <34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group (11/68 [16.2%] vs 26/66 [39.4%]; relative risk, 0.41; 95% confidence interval, 0.22-0.76). Pessary use was associated with a significant reduction in the rate of birthweight <2500 g (P = .01). No significant differences were observed in composite neonatal morbidity outcome (8/136 [5.9%] vs 12/130 [9.1%]; relative risk, 0.64; 95% confidence interval, 0.27-1.50) or neonatal mortality (none) between the groups. No serious adverse effects associated with the use of a cervical pessary were observed.

Conclusion

The insertion of a cervical pessary was associated with a significant reduction in the SPB rate. We propose the use of a cervical pessary for preventing preterm birth in twin pregnancies of mothers with a short cervix.