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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Abnormal Uterine Bleeding; Scar Niche
• Intervention / Treatment: Drug: Misoprostol 200mcg Tab; Procedure: Hysteroscopic resection of uterine niche; Diagnostic test: Saline-infusion Sonohysterography; Other: Placebo tab

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qalyubia Governorate
    • Banhā, Qalyubia Governorate, Egypt, 13512
      • Benha Univesity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Misoprostol group; Misoprostol group received 200 µg sublingual misoprostol tablet two hours before hysteroscopic resection of uterine niche.	Drug: Misoprostol 200mcg Tab; 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; Procedure: Hysteroscopic resection of uterine niche; 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.; Diagnostic test: Saline-infusion Sonohysterography; 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.
Placebo Comparator: Placebo group; Placebo group received sublingual identical placebo tablet two hours before hysteroscopic resection of uterine niche.	Procedure: Hysteroscopic resection of uterine niche; 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.; Diagnostic test: Saline-infusion Sonohysterography; 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.; Other: Placebo tab; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in number of days of postmenstrual spotting.	The number of days of postmenstrual spotting was recorded at baseline and 3 months post hysteroscopic resection of uterine niche.	At 3 months postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total bleeding days per cycle	Total bleeding days per cycle was recorded at baseline and 3 months post hysteroscopic resection of uterine niche.	At baseline and at 3 months postoperative.
Pelvic pain score	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.	At baseline and at 3 months postoperative.
Dysmenorrhea score	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.	At baseline and at 3 months postoperative.
Dyspareunia score	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.	At baseline and at 3 months postoperative.
Dysuria score	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.	At baseline and at 3 months postoperative.
Satisfaction with the outcome	Participant satisfaction with the outcome was assessed using a binary scale (Yes when satisfied/very satisfied , No when dissatisfied/neutral).	At 3 months postoperative.
Uterine niche measurements	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.	At baseline and at 3 months postoperative.

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: AHMED ALNEZAMY, MD, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University

Publications and helpful links

General Publications

• Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.
• Zhuo Z, Yu H, Jiang X. A systematic review and meta-analysis of randomized controlled trials on the effectiveness of cervical ripening with misoprostol administration before hysteroscopy. Int J Gynaecol Obstet. 2016 Mar;132(3):272-7. doi: 10.1016/j.ijgo.2015.07.039. Epub 2015 Dec 11.
• Tanha FD, Salimi S, Ghajarzadeh M. Sublingual versus vaginal misoprostol for cervical ripening before hysteroscopy: a randomized clinical trial. Arch Gynecol Obstet. 2013 May;287(5):937-40. doi: 10.1007/s00404-012-2652-4. Epub 2012 Dec 4.
• Sanders AP, Murji A. Hysteroscopic repair of cesarean scar isthmocele. Fertil Steril. 2018 Aug;110(3):555-556. doi: 10.1016/j.fertnstert.2018.05.032.
• Feng YL, Li MX, Liang XQ, Li XM. Hysteroscopic treatment of postcesarean scar defect. J Minim Invasive Gynecol. 2012 Jul-Aug;19(4):498-502. doi: 10.1016/j.jmig.2012.03.010. Epub 2012 May 22.
• Nguyen AD, Nguyen HTT, Duong GTT, Phan TTH, Do DT, Tran DA, Nguyen TK, Nguyen TB, Ville Y. Improvement of symptoms after hysteroscopic isthmoplasty in women with abnormal uterine bleeding and expected pregnancy: A prospective study. J Gynecol Obstet Hum Reprod. 2022 Mar;51(3):102326. doi: 10.1016/j.jogoh.2022.102326. Epub 2022 Jan 25.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Estimated): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Misoprostol; Hysteroscopy; Administration, Sublingual; Cesarean Section Scar Defect; Cervical Priming; Postmenstrual Spotting
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Hemorrhage; Uterine Hemorrhage; Pathological Conditions, Signs and Symptoms; Metrorrhagia; Fatty Acids; Lipids; Biological Factors; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Prostaglandins E, Synthetic; Misoprostol
• Other Study ID Numbers: RC11-2-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No