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临床试验/NCT07271056
NCT07271056已完成不适用

Sublingual Misoprostol Versus No Cervical Priming Before Hysteroscopic Resection of Symptomatic Uterine Niches: Results From a Prospective Randomized Controlled Trial

Benha University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年2月11日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Reduction in number of days of postmenstrual spotting.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ≥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

排除标准

  • 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

研究组 & 干预措施

Misoprostol group

Active Comparator

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

干预措施: Misoprostol 200mcg Tab (Drug)

Misoprostol group

Active Comparator

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

干预措施: Hysteroscopic resection of uterine niche (Procedure)

Misoprostol group

Active Comparator

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

干预措施: Saline-infusion Sonohysterography (Diagnostic Test)

Placebo group

Placebo Comparator

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

干预措施: Placebo tab (Other)

Placebo group

Placebo Comparator

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

干预措施: Hysteroscopic resection of uterine niche (Procedure)

Placebo group

Placebo Comparator

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

干预措施: Saline-infusion Sonohysterography (Diagnostic Test)

结局指标

主要结局

Reduction in number of days of postmenstrual spotting.

时间窗: At 3 months postoperative.

The number of days of postmenstrual spotting was recorded at baseline and 3 months post hysteroscopic resection of uterine niche.

次要结局

  • Total bleeding days per cycle(At baseline and at 3 months postoperative.)
  • Pelvic pain score(At baseline and at 3 months postoperative.)
  • Dysmenorrhea score(At baseline and at 3 months postoperative.)
  • Dyspareunia score(At baseline and at 3 months postoperative.)
  • Dysuria score(At baseline and at 3 months postoperative.)
  • Satisfaction with the outcome(At 3 months postoperative.)
  • Uterine niche measurements(At baseline and at 3 months postoperative.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Abdel Latif Ahmed Alnezamy

Principal Investigator and Lecturer of Obstetrics and Gynecology, Faculty of Medicine

Benha University

研究点 (1)

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