Abstract
Background: Cervical insufficiency is the responsible factor for 15-25% of pregnancy loss in the second trimester. Midwifery specialists sometimes prefer to use adjunctive therapy in combination with cerclage surgery for management of cervical insufficiency. The aim of this study was to evaluate the effectiveness of adjunctive pessary therapy after cerclage in improving perinatal and neonatal outcome and increasing satisfaction in women with cervical insufficiency.Methods: This concurrent randomized clinical trial was conducted at the infertility department of Royan Institute, Tehran, Iran from May 2018 to May 2020. In this trial, 170 singleton pregnant women, diagnosed with cervical insufficiency, of gestational age 14 to 26 weeks, were enrolled. Patients were randomized 1:1 to receive either cervical cerclage or pessary after cerclage. The primary outcomes were gestational age at the time of delivery and the percentage of preterm labor (<37 weeks). The secondary outcomes were the method of delivery, neonatal outcomes, maternal adverse events and maternal satisfaction of interventions.Results: Preterm birth before 37 weeks of gestation occurred in 16 women (19.3%) in the pessary group and 17 women (21%) in the control group (between-group difference, 1.11%; 95%CI 0.518−2.388%). In the survival analysis to 37 WK of gestation, the incidence of preterm birth was not significantly different between the two groups (Relative Risk (RR), 1; 95%CI, 0.161-6.202). Based on survival analysis, the incidence of vaginal bleeding and pelvic pain significantly differed between the two groups (RR, 2.68; 95%CI (1.31-5.46)) and (RR, 1.73; 95%CI (1.04-2.87), respectively. The mean score of satisfaction in the intervention group (5.73) was significantly higher than the control group (5.25), (between-group difference, 0.47; 95%CI (0.10-0.84).Conclusions: The placement of an adjunctive pessary for pregnant women with singleton pregnancy and a cervical insufficiency, did not result in a lower rate of preterm delivery before 37 weeks of gestation compared to cerclage alone. However, the complications of pregnancy after the intervention until delivery, were less in these women, while the level of satisfaction was higher. Trial registration: Iranian Registry of Clinical Trials (IRCT20180302038914N1), May 5,2018.
17-Hydroxyprogesterone caproate to prolong pregnancy after preterm rupture of the membranes: early termination of a double-blind, randomized clinical trial
