Subject(s)
COVID-19 Vaccines , Clinical Trials as Topic , Patient Selection , COVID-19 , Female , Humans , Pregnancy , Pregnant WomenABSTRACT
BACKGROUND: Different factors may influence the closure of the uterine wall, including suture material. Suture materials may indeed influence tissue healing and therefore the development of scar defects. OBJECTIVE: To test whether uterine closure using synthetic absorbable monofilament sutures at the time of cesarean delivery would reduce the rate of cesarean scar defects compared with uterine closure using synthetic absorbable multifilament sutures. STUDY DESIGN: Parallel-group, nonblinded, randomized clinical trial of women with singleton pregnancies undergoing cesarean delivery at term in a single center in Italy. The inclusion criteria were singleton pregnancy, first or second cesarean delivery, scheduled and emergent or urgent cesarean deliveries, and gestational age between 37 0/7 and 42 0/7 weeks. Eligible participants were randomly allocated in a 1:1 ratio to either the monofilament group (polyglytone 6211 [Caprosyn]; Covidien, Dublin, Ireland) or the multifilament suture group (coated polyglactin 910 suture with Triclosan [Vicryl Plus]; Ethicon, Inc, Raritan, NJ). The primary outcome was the incidence of cesarean scar defect at ultrasound at the 6-month follow-up visit. The secondary outcomes were residual myometrial thickness and symptoms. RESULTS: Overall, 300 women were included in the trial. Of the randomized women, 151 were randomized to the monofilament group and 149 to the multifilament group. However, 27 women were lost to follow-up: 15 in the monofilament group and 12 in the multifilament group. Of note, 6 months after delivery, the incidence rates of cesarean scar defect were 18.4% (25 of 136 patients) in the monofilament group and 23.4% (32 of 137 patients) in the multifilament group (relative risk, 0.79; 95% confidence interval, 0.41-1.25; P=.31). The mean residual myometrial thicknesses were 7.6 mm in the monofilament group and 7.2 mm in the multifilament group (mean difference, +0.40 mm; 95% confidence interval, -0.23 to 1.03). There was no between-group substantial difference found in the incidence of symptoms, including pelvic pain, painful periods, and dyspareunia. CONCLUSION: In singleton pregnancies undergoing primary or second cesarean delivery, the use of synthetic absorbable monofilament sutures at the time of uterine wall closure was not associated with a reduction in the rate of cesarean scar defect 6 months after delivery compared with the use of synthetic absorbable multifilament sutures.