Sublingual Misoprostol Versus No Cervical Priming Before Hysteroscopic Resection of Symptomatic Uterine Niches
NCT ID: NCT07271056
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2025-02-11
2025-10-30
Brief Summary
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Detailed Description
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The participants, hysteroscopist, outcome assessors, and the investigator were blinded for the assignment of the participants to either groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Misoprostol group
Misoprostol group received 200 µg sublingual misoprostol tablet two hours before hysteroscopic resection of uterine niche.
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.
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.
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 group
Placebo group received sublingual identical placebo tablet two hours before hysteroscopic resection of uterine niche.
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.
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.
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.
Interventions
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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.
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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Amenorrhea
* Abnormal cervical cytology
* Acute or chronic cervicitis
* Pelvic inflammatory disease
* Endometrial polyps
* Uterine fibroids
* Contraindications to spinal or general anesthesia
* Refusal to participate
18 Years
45 Years
FEMALE
No
Sponsors
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Benha University
OTHER
Responsible Party
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Ahmed Abdel Latif Ahmed Alnezamy
Principal Investigator and Lecturer of Obstetrics and Gynecology, Faculty of Medicine
Principal Investigators
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AHMED ALNEZAMY, MD
Role: PRINCIPAL_INVESTIGATOR
Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University
Locations
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Benha Univesity Hospital
Banhā, Qalyubia Governorate, Egypt
Countries
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References
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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.
Other Identifiers
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RC11-2-2025
Identifier Type: -
Identifier Source: org_study_id