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Study Objective: To evaluate the safety and potential efficacy of a novel degradable polymer film (DPF) designed to act as a 7-day barrier to prevent intrauterine adhesions (IUAs) after hysteroscopic myomectomy., Design: A prospective single-arm, first-in-human clinical study., Setting: Multicenter study involving 6 centers in France, Belgium, and the Netherlands., Patients: Women aged 40 years or older with no plans to conceive who qualified for hysteroscopic myomectomy (at least 1 10-mm type 0, 1, or 2 myoma) and had a sounded length of the uterine cavity (fundus to exocervix) ranging between 6 cm and 9 cm were considered eligible for the study., Interventions: The DPF was inserted after hysteroscopic transcervical myoma resection. The women were followed up by a telephone call at 30 days and second-look hysteroscopy 4 to 8 weeks after the procedure., Measurements and Main Results: The chosen safety outcome measures were uterine perforation or cervical trauma at the time of the DPF insertion and unexpected fever, pain, or bleeding beyond 48 hours and up to 30 days after insertion, whereas the outcome measure for efficacy was the absence of IUAs on second-look hysteroscopy. A total of 23 women participated in the study. There were no incidents of uterine perforation or cervical trauma at the time of the DPF insertion. There were no reported adverse effects attributable to the DPF. On second-look hysteroscopy, 20 (87%) of the 23 women had no IUAs., Conclusion: The DPF is a novel, easy-to-apply, and acceptable device to prevent IUAs, with very promising initial safety and efficacy data., (Copyright © 2021 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: To study the safety of a degradable polymeric film (DPF) and its efficacy on reducing the risk of intrauterine-adhesion (IUA) formation in a rat model., Design: A series of case-control studies relying on random allocation, where feasible., Setting: University and good practice animal laboratories., Animals: The animal models comprised female and male Oncins France Strain A and female Wistar rats., Intervention(s) and Measurements: The Oncins France Strain A rats were used for in vivo evaluation of the impact of the DPF on endometrial thickness and its effect on fertility. For in vivo evaluation of the biologic response, 40 Wistar rats were randomly allocated to intervention and control groups, with matched sampling time after surgery. Finally, for the in vivo evaluation of the DPF's efficacy on IUA prevention, a total of 24 Wistar rats were divided into 3 groups: 1 treated with the DPF, 1 treated with hyaluronic acid gel, and a sham group., Main Results: The DPF did not have a significant impact on endometrial thickness, and there were no significant differences in the number of conceived or prematurely terminated pregnancies, confirming its noninferiority to no treatment. The DPF did not induce irritation at 5 days and 28 days. Finally, the DPF significantly reduced the likelihood of complete IUA formation compared with hyaluronic acid gel- and sham-implanted animals, where only 27% of the animals had their uterine cavity obliterated compared with 80% and 100%, respectively., Conclusion: The DPF is a safe film that is effective in preventing IUA formation after intrauterine curettage in rats., (Copyright © 2020 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: To describe a novel technique of transvaginal cervicoisthmic cerclage with a polypropylene sling in prevention of preterm labor in pregnant women at high risk., Design: Retrospective study (Canadian Task Force classification: III)., Setting: University hospital (department of obstetrics and gynecology)., Patients: Twenty-one women showing symptoms of high risk of preterm delivery: histories of pregnancy losses in the second trimester and prior failure of MacDonald's cerclage or absent portio vaginalis of the cervix. The median age of the patients was 32.8 years (range 22-39 years)., Interventions: Cerclage was performed between 12 and 16 weeks' gestation. A polypropylene tape was placed at the cervicoisthmic junction by vaginal route. Caesarean delivery was systematically performed in all patients because the cerclage was considered to be definitive., Measurements and Main Results: No intraoperative complications occurred. The mean operating time was 36 +/- 6 minutes (range 30-45 minutes). The mean length of stay was 1.4 +/- 0.5 days. Mean gestational age and birth weight at delivery were respectively 37.1 +/- 1.8 weeks (CI 95%: 36.4-37.9) and 2850 +/- 745 g (CI 95%: 2531-3168). The preterm birth rate was 19% (4/21). One neonatal death occurred after amniotic fluid infection at 34 weeks. Birth at less than 32 weeks occurred in one patient (4%)., Conclusion: Transvaginal cervicoisthmic cerclage with polypropylene sling may be considered as an effective and minimally invasive alternative to the transabdominal cervicoisthmic cerclage in women presenting with high risk of preterm delivery.