Sublingual Misoprostol Versus No Cervical Priming Before Hysteroscopic Resection of Symptomatic Uterine Niches

Benha University

Status: Completed

Conditions: Cesarean Section Complications; Scar Niche; Abnormal Uterine Bleeding

Treatments: Diagnostic Test: Saline-infusion Sonohysterography; Drug: Misoprostol 200mcg Tab; Other: Placebo tab; Procedure: Hysteroscopic resection of uterine niche

Study type: Interventional

Funder types: Other

Identifiers

NCT07271056

RC11-2-2025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 56 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥1 previous cesarean section
• Post cesarean section uterine niche confirmed by saline infusion sonohysterography (niche depth ≥2 mm)
• Residual myometrial thickness ≥2.5 mm as confirmed by saline infusion sonohysterography
• Regular cycles
• Abnormal uterine bleeding for ≥3 consecutive cycles
• Post menstrual spotting or brownish discharge ≥2 days
• Total monthly bleeding duration >7 days

Exclusion criteria

• Irregular cycles
• Amenorrhea
• Abnormal cervical cytology
• Acute or chronic cervicitis
• Pelvic inflammatory disease
• Endometrial polyps
• Uterine fibroids
• Contraindications to spinal or general anesthesia
• Refusal to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

Misoprostol group

Active Comparator group

Description:

Misoprostol group received 200 µg sublingual misoprostol tablet two hours before hysteroscopic resection of uterine niche.

Treatment:

Procedure: Hysteroscopic resection of uterine niche

Drug: Misoprostol 200mcg Tab

Diagnostic Test: Saline-infusion Sonohysterography

Placebo group

Placebo Comparator group

Description:

Placebo group received sublingual identical placebo tablet two hours before hysteroscopic resection of uterine niche.

Treatment:

Procedure: Hysteroscopic resection of uterine niche

Other: Placebo tab

Diagnostic Test: Saline-infusion Sonohysterography