Cerclage in singleton pregnancies with no prior spontaneous PTB and short cervix: a randomized controlled trial
Abstract
BACKGROUND
PTB (PTB) remains a leading cause of neonatal morbidity and mortality. Cerclage for short cervical length (CL) ≤25mm in singletons with a history of spontaneous PTB is associated with decreased neonatal morbidity/mortality. Both vaginal progesterone and cerclage individually have level 1 evidence supporting benefit in prevention of PTB in pregnancies complicated by short CL, however there is a paucity of level 1 evidence regarding the potential benefit of cerclage with progesterone compared to progesterone alone for short CL ≤25mm in singletons without a history of spontaneous PTB.
OBJECTIVE
We aimed to conduct a pragmatic randomized controlled trial to evaluate the additional benefit of cerclage with vaginal progesterone compared to vaginal progesterone alone in singletons without prior spontaneous PTB and with a current mid-trimester transvaginal ultrasound (TVU) CL ≤25mm STUDY DESIGN: This is a multicenter international randomized controlled trial from 09/2017-09/2023 with four sites in the United States and Italy. Singleton pregnancies without prior spontaneous PTB received TVUCL (universal) screening during mid-trimester anatomy ultrasound as part of routine care. Inclusion criteria was TVUCL≤25mm at 18 0/7 - 23 6/7 weeks. Exclusion criteria included current or planned cerclage, cervical dilation, symptoms of labor, infection, bleeding, rupture of membranes at screening. Participants were randomized 1:1 to cerclage with vaginal progesterone (200mg vaginal…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 206 participants or records.
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