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

NCT07271056 | Completed

• 1 other identifier: RC11-2-2025
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scar Niche; Abnormal Uterine Bleeding; Cesarean Section Complications

Keywords

Misoprostol; Administration, Sublingual; Cervical Priming; Hysteroscopy; Cesarean Section Scar Defect; Randomized Controlled Trial; Postmenstrual Spotting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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.

Study Arms (2)

Misoprostol group

ACTIVE COMPARATOR

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

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

Placebo group

PLACEBO COMPARATOR

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

Other: Placebo tab; Procedure: Hysteroscopic resection of uterine niche; Diagnostic Test: Saline-infusion Sonohysterography

Interventions

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.

Also known as: Misotac®, Sigma Pharmaceutical Industries, Egypt

Misoprostol group

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.

Placebo group

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.

Misoprostol group; Placebo group

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.

Misoprostol group; Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha Univesity Hospital

Banhā, Qalyubia Governorate, 13512, Egypt

Location

Related Publications (6)

• 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.

  PMID: 29536581 BACKGROUND

• 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.

  PMID: 26797202 BACKGROUND

• 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.

  PMID: 23208460 BACKGROUND

• 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.

  PMID: 30098702 RESULT

• 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.

  PMID: 22621994 RESULT

• 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.

  PMID: 35091125 RESULT

MeSH Terms

Conditions

Metrorrhagia

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• AHMED ALNEZAMY, MD

  Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Lecturer of Obstetrics and Gynecology, Faculty of Medicine

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 8, 2025
• Study Start: February 11, 2025
• Primary Completion: July 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)