Cervical Stitch (Cerclage) for Preventing Pregnancy Loss: Individual Patient Data Meta-Analysis

Abstract

Numerous observational studies done over the past 5 decades have claimed improved pregnancy outcomes in women with cervical insufficiency following cerclage—placement of a purse-type stitch to keep the cervix closed during pregnancy. A recent Cochrane review of randomized trials found no persuasive evidence of benefit, but there was significant heterogeneity for some important clinical outcomes which was ascribed to inconsistent clinical definitions and the different patient populations studied. The present investigators undertook an individual patient data (IPD) meta-analysis to determine the effects of cerclage, if any, on both neonatal and maternal outcomes. Seven randomized trials, including 2091 women with suspected or confirmed cervical insufficiency, compared cervical cerclage during pregnancy with expectant management or no cerclage and were included in the analysis. Multilevel logistic regression analysis, stratified by trial, was used to examine the impact of obstetrical factors and multiple gestation on treatment effects. The major indications for cerclage in the trials reviewed were the sonographic finding of a short cervix or an obstetrical history consistent with cervical incompetence. In singleton pregnancies, there was no significant reduction in pregnancy loss or infant death before hospital discharge following cerclage. The odds ratio (OR) was 0.81, with a 95% confidence interval (CI) of 0.60 to 1.10. In multiple gestations, cerclage adversely affected these outcomes (OR, 5.88; 95% CI, 1.14–30.19). Neither the indication for cerclage nor the obstetrical history was significantly associated with the effect of cerclage. The overall results of this IPD meta-analysis suggest that, in singleton pregnancies, cervical cerclage does not significantly lessen the risk of pregnancy loss or early infant death in pregnancies with an elevated risk of preterm birth. In multiple gestations, cerclage is associated with a worse outcome compared to no cerclage.