Uterine Scar Resection During Repeat Cesarean Delivery to Prevent Uterine Niche Formation
NCT ID: NCT07228858
Last Updated: 2025-12-29
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
170 participants
INTERVENTIONAL
2025-02-09
2025-11-30
Brief Summary
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Detailed Description
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* Study group: During repeat cesarean section, the prior uterine scar was resected. After creating the bladder flap, the uterus was incised 5 mm cranial to the scar and extended laterally 5 mm beyond its ends. Following delivery, a 1 cm segment of uterine wall (5 mm above and below the scar) was excised. The incision edges were approximated with a central vertical mattress suture, followed by double-layer continuous myometrial closure (including decidua) and visceral peritoneum closure.
* Control group: Standard repeat cesarean section without scar resection, followed by identical double-layer and peritoneal closure.
All procedures were performed by obstetricians trained in the protocol. All women received standard preoperative antibiotics, 24-hour postoperative prophylaxis, and 10 units intramuscular oxytocin after delivery.
At 6 months postpartum, all participants will undergo transvaginal ultrasound and saline infusion sonohysterography performed by a blinded, experienced examiner. Sagittal and coronal views willl be obtained, and niche presence, depth, length, width, and residual myometrial thickness are to be recorded.
Obstetricians were informed of assignment, while participants and ultrasound assessor are blinded.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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uterine scar resection
During repeat cesarean section, the previous uterine cesarean section scar was resected.
Repeated cesarean section with previous uterine cesarean section scar resection
After creating the bladder flap, the uterus was incised 5 mm cranial to the scar and extended laterally 5 mm beyond its ends. After delivery of the newborn, a 1 cm segment of uterine wall (5 mm above and 5 mm below the scar) was excised. The incision edges were approximated with a central vertical mattress suture, followed by double-layer continuous myometrial closure including decidua with visceral peritoneum closure.
Saline-infusion Sonohysterography
At 6 months postpartum, all participants are to be 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 is defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness are to be recorded.
Non scar resection
Standard repeat cesarean section without previous uterine cesarean section scar resection.
Repeated cesarean section without uterine scar resection
Standard repeat cesarean section without scar resection, followed by double-layer continuous myometrial closure including decidua with visceral peritoneum closure.
Saline-infusion Sonohysterography
At 6 months postpartum, all participants are to be 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 is defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness are to be recorded.
Interventions
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Repeated cesarean section with previous uterine cesarean section scar resection
After creating the bladder flap, the uterus was incised 5 mm cranial to the scar and extended laterally 5 mm beyond its ends. After delivery of the newborn, a 1 cm segment of uterine wall (5 mm above and 5 mm below the scar) was excised. The incision edges were approximated with a central vertical mattress suture, followed by double-layer continuous myometrial closure including decidua with visceral peritoneum closure.
Repeated cesarean section without uterine scar resection
Standard repeat cesarean section without scar resection, followed by double-layer continuous myometrial closure including decidua with visceral peritoneum closure.
Saline-infusion Sonohysterography
At 6 months postpartum, all participants are to be 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 is defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness are to be recorded.
Eligibility Criteria
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Inclusion Criteria
* Undergoing repeat cesarean section for any indication.
* Provided informed consent and agreed to 6-month postpartum follow-up.
* Not planning pregnancy during follow-up.
Exclusion Criteria
* Hepatic or renal dysfunction, uncontrolled diabetes, or hemoglobin \<10 g/dL.
* Systemic uncontrolled disease, chronic corticosteroid use, or smoking.
* Inability to provide informed consent.
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
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.
Klein Meuleman SJM, Min N, Hehenkamp WJK, Post Uiterweer ED, Huirne JAF, de Leeuw RA. The definition, diagnosis, and symptoms of the uterine niche - A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Aug;90:102390. doi: 10.1016/j.bpobgyn.2023.102390. Epub 2023 Jul 15.
Vervoort A, Vissers J, Hehenkamp W, Brolmann H, Huirne J. The effect of laparoscopic resection of large niches in the uterine caesarean scar on symptoms, ultrasound findings and quality of life: a prospective cohort study. BJOG. 2018 Feb;125(3):317-325. doi: 10.1111/1471-0528.14822. Epub 2017 Aug 28.
Baranov A, Gunnarsson G, Salvesen KA, Isberg PE, Vikhareva O. Assessment of Cesarean hysterotomy scar in non-pregnant women: reliability of transvaginal sonography with and without contrast enhancement. Ultrasound Obstet Gynecol. 2016 Apr;47(4):499-505. doi: 10.1002/uog.14833. Epub 2016 Feb 29.
Osser OV, Jokubkiene L, Valentin L. High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2009 Jul;34(1):90-7. doi: 10.1002/uog.6395.
Osser OV, Jokubkiene L, Valentin L. Cesarean section scar defects: agreement between transvaginal sonographic findings with and without saline contrast enhancement. Ultrasound Obstet Gynecol. 2010 Jan;35(1):75-83. doi: 10.1002/uog.7496.
Sholapurkar SL. Etiology of Cesarean Uterine Scar Defect (Niche): Detailed Critical Analysis of Hypotheses and Prevention Strategies and Peritoneal Closure Debate. J Clin Med Res. 2018 Mar;10(3):166-173. doi: 10.14740/jocmr3271w. Epub 2018 Jan 26.
Siraj SHM, Lional KM, Tan KH, Wright A. Repair of the myometrial scar defect at repeat caesarean section: a modified surgical technique. BMC Pregnancy Childbirth. 2021 Aug 17;21(1):559. doi: 10.1186/s12884-021-04040-9.
Other Identifiers
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RC9-2-2025
Identifier Type: -
Identifier Source: org_study_id