Uterine Scar Resection During Repeat Cesarean Delivery to Prevent Uterine Niche Formation

NCT07228858 | Completed

• 1 other identifier: RC9-2-2025
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate whether resection of the previous cesarean scar at repeat cesarean delivery reduces uterine niche formation and related morbidity without increasing operative risks.

Conditions

Cesarean Section Complications; Scar Niche; Scarred Uterus

Keywords

Repeated cesarean section; Uterine niche; Scar resection; Residual myometrial thickness; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Rate of uterine niche formation after repeated cesarean section

  Using saline-infusion sonohysterography (2 dimensional, sagittal and coronal views). A niche is defined as ≥ 2 mm myometrial indentation at the scar site.

  At 6 months postpartum

Secondary Outcomes (5)

• Total operative time.

  Intraoperative

• The mean estimated intraoperative blood loss.

  Intraoperative

• The number of additional hemostatic sutures needed.

  immediately postoperative

• Uterine niche measurments

  At 6 months postpartum

• Menstrual characteristics among participants with uterine niche

  At 6 months postpartum

Study Arms (2)

uterine scar resection

ACTIVE COMPARATOR

During repeat cesarean section, the previous uterine cesarean section scar was resected.

Procedure: Repeated cesarean section with previous uterine cesarean section scar resection; Diagnostic Test: Saline-infusion Sonohysterography

Non scar resection

ACTIVE COMPARATOR

Standard repeat cesarean section without previous uterine cesarean section scar resection.

Procedure: Repeated cesarean section without uterine scar resection; Diagnostic Test: Saline-infusion Sonohysterography

Interventions

Repeated cesarean section without uterine scar resection PROCEDURE

Standard repeat cesarean section without scar resection, followed by double-layer continuous myometrial closure including decidua with visceral peritoneum closure.

Non scar resection

Repeated cesarean section with previous uterine cesarean section scar resection PROCEDURE

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.

uterine scar resection

Saline-infusion Sonohysterography DIAGNOSTIC_TEST

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; uterine scar resection

Eligibility Criteria

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

You may qualify if:

• ≥1 prior cesarean section at ≥28 weeks' gestation.
• Undergoing repeat cesarean section for any indication.
• Provided informed consent and agreed to 6-month postpartum follow-up.
• Not planning pregnancy during follow-up.

You may not qualify if:

• Uterine fibroids, multiple gestation, chorioamnionitis, placenta previa, placental abruption, or preeclampsia/eclampsia.
• Hepatic or renal dysfunction, uncontrolled diabetes, or hemoglobin \<10 g/dL.
• Systemic uncontrolled disease, chronic corticosteroid use, or smoking.
• Inability to provide informed consent.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha Univesity Hospital

Banhā, Qalyubia Governorate, 13512, Egypt

Location

Related Publications (8)

• 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

• 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.

  PMID: 37506497 BACKGROUND

• 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.

  PMID: 28703935 BACKGROUND

• 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.

  PMID: 25720922 BACKGROUND

• 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.

  PMID: 19499514 RESULT

• 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.

  PMID: 20034000 RESULT

• 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.

  PMID: 29416572 RESULT

• 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.

  PMID: 34404382 RESULT

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Eligible women were randomized (1:1) using a computer-generated sequence in blocks of 10. Allocation was concealed in sequentially numbered, opaque, sealed envelopes opened by a trained nurse after consent. Obstetricians were informed of assignment, while participants , investigator, and ultrasound assessors remained blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology, Faculty of Medicine

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: February 9, 2025
• Primary Completion: May 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)