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Sublingual Misoprostol Versus No Cervical Priming Before Hysteroscopic Resection of Symptomatic Uterine Niches: Results From a Prospective Randomized Controlled Trial
The purpose of the study is to evaluated whether preoperative sublingual misoprostol can enhance the effectiveness and safety of niche resection in patients with symptomatic uterine niche.
After eligibility and consenting, Participants with symptomatic uterine niche were randomized (1:1) to sublingual misoprostol or placebo. Baseline demographic and clinical variables (age, BMI, number of prior cesarean section, number of days of postmenstrual spotting, pelvic pain, dysmenorrhea, dyspareunia, and dysuria) were collected. Symptom severity was assessed using a visual analogue scale (VAS, 1-10). Baseline niche characteristics (residual myometrial thickness, depth, length, and width) were measured by saline infusion sonohysterography. The misoprostol group received 200 µg sublingual misoprostol tablet two hours before surgery; controls received identical placebo tablets. Hysteroscopic resection of uterine niche was performed around cycle day 10 under spinal or general anesthesia using a 9-mm resectoscope with monopolar energy and 3.5% sorbitol for uterine distension. Misoprostol-related adverse events (cramping, fever, GI upset) were recorded preoperatively by a trained nurse. The Sanders and Murji technique was adapted as follow: (1) anatomical orientation, (2) cephalic rim resection, (3) caudal rim resection, and (4) rollerball ablation of the niche base . Intraoperative data (duration, need for dilators, intra- and postoperative complications). At 3 months postoperatively, participants were reassessed for reduction in number of days of postmenstrual spotting, changes in pelvic pain, dysmenorrhea, dyspareunia, and dysuria (VAS scores), participants satisfaction (satisfied/very satisfied vs. dissatisfied/neutral), , and sonohysterographic niche measurements (RMT, depth, length, width). The participants, hysteroscopist, outcome assessors, and the investigator were blinded for the assignment of the participants to either groups.
Age
18 - 45 years
Sex
FEMALE
Healthy Volunteers
No
Benha Univesity Hospital
Banhā, Qalyubia Governorate, Egypt
Start Date
February 11, 2025
Primary Completion Date
July 30, 2025
Completion Date
October 30, 2025
Last Updated
December 16, 2025
56
ACTUAL participants
Misoprostol 200mcg Tab
DRUG
Placebo tab
OTHER
Hysteroscopic resection of uterine niche
PROCEDURE
Saline-infusion Sonohysterography
DIAGNOSTIC_TEST
Lead Sponsor
Benha University
NCT06024109
NCT04307069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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