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Completed

NCT Number: NCT07271056

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol 200Mcg Tab

Drug

Misoprostol group received 200 µg sublingual misoprostol tablet two hours before hysteroscopic resection of uterine niche. A trained nurse, independent of assessment, prepared and administered the medication to the participants.

Other names: Misotac®, Sigma Pharmaceutical Industries, Egypt

Placebo tab

Other

Placebo group received sublingual identical tablet two hours before hysteroscopic resection of uterine niche. A trained nurse, independent of assessment, prepared and administered the tab to the participants.

Hysteroscopic resection of uterine niche

Procedure

Procedures were performed around cycle day 10 under spinal or general anesthesia using a 9-mm resectoscope (Karl Storz, Germany) with monopolar energy and 3.5% sorbitol for uterine distension. 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.

Saline-infusion Sonohysterography

Diagnostic Test

All participants were evaluated by a single blinded sonographer experienced in niche assessment. First, transvaginal ultrasound was performed to exclude pregnancy or pelvic pathology, followed by saline-infusion sonohysterography (2D, sagittal and coronal views). A niche was defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness were recorded.

Primary outcomes

  1. Reduction in number of days of postmenstrual spotting.

    Time frame: At 3 months postoperative.

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

Secondary outcomes

  1. Total bleeding days per cycle

    Time frame: At baseline and at 3 months postoperative.

    Total bleeding days per cycle was recorded at baseline and 3 months post hysteroscopic resection of uterine niche.

  2. Pelvic pain score

    Time frame: At baseline and at 3 months postoperative.

    Pain was assessed using a 10-cm Visual Analog Scale (VAS). Participants mark a point on the line that represents their pain,giving that 0 means no pain and 10 means worst pain imaginable. The clinician measures the distance (in centimeters or millimeters) from 0 to the patient's mark and that number is the VAS pain score.

  3. Dysmenorrhea score

    Time frame: At baseline and at 3 months postoperative.

    Pain was assessed using a 10-cm Visual Analog Scale (VAS). Participants mark a point on the line that represents their pain,giving that 0 means no pain and 10 means worst pain imaginable. The clinician measures the distance (in centimeters or millimeters) from 0 to the patient's mark and that number is the VAS pain score.

  4. Dyspareunia score

    Time frame: At baseline and at 3 months postoperative.

    Pain was assessed using a 10-cm Visual Analog Scale (VAS). Participants mark a point on the line that represents their pain,giving that 0 means no pain and 10 means worst pain imaginable. The clinician measures the distance (in centimeters or millimeters) from 0 to the patient's mark and that number is the VAS pain score.

  5. Dysuria score

    Time frame: At baseline and at 3 months postoperative.

    Pain was assessed using a 10-cm Visual Analog Scale (VAS). Participants mark a point on the line that represents their pain,giving that 0 means no pain and 10 means worst pain imaginable. The clinician measures the distance (in centimeters or millimeters) from 0 to the patient's mark and that number is the VAS pain score.

  6. Satisfaction with the outcome

    Time frame: At 3 months postoperative.

    Participant satisfaction with the outcome was assessed using a binary scale (Yes when satisfied/very satisfied , No when dissatisfied/neutral).

  7. Uterine niche measurements

    Time frame: At baseline and at 3 months postoperative.

    First, transvaginal ultrasound was performed to exclude pregnancy or pelvic pathology, followed by saline-infusion sonohysterography (2D, sagittal and coronal views). A niche was defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness were recorded.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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