Comparing the Efficacy of Pessary as an Adjunctive Therapy after Cerclage, and Cerclage Alone in Prevention of Spontaneous Preterm Birth: A Randomized Controlled Trial

Background & Objective: The aim of this study was to evaluate the effectiveness of adjunctive pessary therapy after cerclage in increasing the gestational age (GA) to 37 weeks in women with cervical insufficiency (CI). Materials & Methods: This randomized controlled trial (RCT) was conducted at the infertility department of Royan Institute, Tehran, Iran. A total of 170 singleton pregnant women aged 18-42 years old, diagnosed with CI by GA 14-24weeks, who had intact membrane with no signs of intrauterine infection, vaginal bleeding, or uterine contraction, were enrolled. Patients were randomized 1:1 to receive either cervical cerclage or pessary after cerclage. The primary outcome was spontaneous preterm birth (SPB) (<37weeks). The secondary outcomes were GA at the time of delivery, SPB (less than 34, 32 & 28 weeks), delivery method, neonatal outcomes, maternal adverse events, and maternal satisfaction with the intervention. Results: The incidence of SPB (<37, 34, 32 & 28weeks), method of delivery, GA at time of delivery, and neonatal outcomes were not significantly different between the two groups. The incidence of vaginal bleeding ( P =0.007) and pelvic pain ( P =0.03) significantly was less in the intervention group. The mean score of satisfaction in the intervention group was significantly higher than the control group ( P =0.01). Conclusion: The placement of an adjunctive pessary for pregnant women with singleton pregnancy and CI, did not result in a lower rate of SPB (<37weeks) compared to cerclage alone. However, pregnancy complications after the intervention until delivery were less in these women, while the level of satisfaction was higher.