The feasibility and effectiveness of using an adhesion barrier in preventing dysmenorrhea, pain, and niche-related problems after cesarean sections: a multicenter randomized pilot study.

Abstract

Background: A cesarean scar can lead to various gynecological complaints, including abdominal pain, dysmenorrhea, postmenstrual spotting, and unexplained secondary infertility. The ethiology of the development of a niche is currently not clear. A possible hypothesis is the involvement of vesicouterine adhesions formed after the cesarean section.

Objective: This study explores the feasibility of a randomized controlled trial assessing the effectiveness of an adhesion barrier on the uterine wound in women undergoing their first cesarean section on gynecological symptoms and the presence of adhesions evaluated by transvaginal ultrasound.

Study design: A multicenter randomized pilot study was performed on women undergoing their first cesarean section. They were randomly allocated to the application of the adhesion barrier 4DryField © PH after uterine closure or no adhesion barrier. They were followed for nine months using transvaginal ultrasound and questionnaires. The primary outcome measure was feasibility (protocol compliance, loss-to-follow-up, data collection). Secondary outcomes were perioperative outcomes, menstrual outcomes, Quality of Life, and sexual function at nine months, as well as ultrasound findings such as vesicouterine adhesion and niche measurements at three months.

Results: One hundred seventeen participants (58 intervention, 59 control) were enrolled. Protocol adherence was 94.8% to 100%, and follow-up loss was 3% to 12%. Difficulties in feasibility included ultrasound evaluation, ultrasound storage, and participant recall bias. At nine months, 40% of participants had amenorrhea and/or gave breastfeeding or used hormonal contraceptives. There was no apparent difference in dysmenorrhea, but postmenstrual spotting was less in the intervention group (0% vs 18.4%, p=0.04). Furthermore, there was a trend toward fewer adhesions and niches in the intervention group.

Conclusions: The study showed no clear limitations, feasible execution of the procedure, and a low drop-out rate. Spotting was less in the intervention group. Nevertheless, a larger sample size is needed to draw solid conclusions concerning the beneficial effect of reducing niches, adhesions, dysmenorrhea, and chronic pelvic pain. Our findings are encouraging and support the design of a comparatively large randomized controlled trial with a refined methodology to enhance feasibility and accuracy.