Effectiveness of cervical pessary compared to cervical cerclage with or without vaginal progesterone for the prevention of preterm birth in women with twin pregnancies and a short cervix: study protocol for a two-by-two factorial randomised clinical trial

Autor: Lan N Vuong, Vinh Q Dang, Yen TN He, Ha NH Pham, Tuyen TT Trieu, Trung Q Bui, Nhu T Vuong, Loc MT Nguyen, Diem TN Nguyen, Thanh V Le, Cam H Le
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: BMJ Open, Vol 10, Iss 6 (2020)
Druh dokumentu: article
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2019-036587
Popis: Introduction Women with twin pregnancies and a short cervix are at increased risk for preterm birth (PTB). Given the burden of prematurity and its attendant risks, the quest for effective interventions in twins has been an area of considerable research. Studies investigating the effectiveness of cervical cerclage, cervical pessary and vaginal progesterone in preventing PTB have yielded conflicting results. The aim of this study is to compare the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone to prevent PTB in women with twin pregnancies and a cervical length (CL) ≤ 28 mm.Methods and analysis This multicentre, randomised clinical trial will be conducted at My Duc Hospital and My Duc Phu Nhuan Hospital, Vietnam. Asymptomatic women with twin pregnancies and a CL ≤28 mm, measured at 16–22 weeks’ gestation, will be randomised in a 1:1:1:1 ratio to receive a cerclage, pessary, cerclage plus progesterone or pessary plus progesterone. Primary outcome will be PTB
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