A Two-Layered Simple Interrupted Myometrial Suturing Reduces Uterine Niche Formation After Primary Cesarean Section

NCT07229222 | Completed

• 1 other identifier: RC13-2-2025
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether two-layered simple interrupted myometrial suturing is superior to double-layered continuous suturing for the prevention of uterine niche formation after primary cesarean section.

Conditions

Cesarean Section Complications; Scar Niche; Myometrial Remodeling; Suture Techniques

Keywords

Uterine niche; Myometrial closure; Residual myometrial thickness; Randomized controlled trial; Cesarean scar disorder

Outcome Measures

Primary Outcomes (1)

• Rate of uterine niche formation after primary cesarean section.

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

  At 6 months postpartum

Secondary Outcomes (4)

• Uterine niche measurements

  At 6 months postpartum

• Total operative time.

  Intraoperative

• The correlation between niche width and menstrual cycle abnormalities.

  At 6 months postpartum

• The association between active labour at the time of cesarean and niche formation.

  Cervical dilatation was evaluated immediately preoperative, while the association was evaluated at 6 months postpartum

Study Arms (2)

Two-layered simple interrupted suturing of the myometrium

ACTIVE COMPARATOR

Two-layered simple interrupted suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum.

Procedure: Primary Cesarean Section with two-layered simple interrupted suturing of the myometrium; Diagnostic Test: Saline-infusion Sonohysterography

Double-layered continuous suturing of the myometrium.

ACTIVE COMPARATOR

Double-layered continuous suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum.

Procedure: Primary Cesarean Section with double-layered continuous suturing of the myometrium; Diagnostic Test: Saline-infusion Sonohysterography

Interventions

Primary Cesarean Section with double-layered continuous suturing of the myometrium PROCEDURE

All steps of cesarean section were standardized for both arms except for the type of myometrial suturing where double-layered continuous suturing of the myometrium was applied.

Double-layered continuous suturing of the myometrium.

Saline-infusion Sonohysterography DIAGNOSTIC_TEST

At 6 months postpartum, all patients 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.

Double-layered continuous suturing of the myometrium.; Two-layered simple interrupted suturing of the myometrium

Primary Cesarean Section with two-layered simple interrupted suturing of the myometrium PROCEDURE

All steps of cesarean section were standardized for both arms except for the type of myometrial suturing where two-layered simple interrupted suturing of the myometrium was applied.

Two-layered simple interrupted suturing of the myometrium

Eligibility Criteria

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

You may qualify if:

• Acceptance to participate and willingness to attend follow-up for 6 months postpartum.
• No plans for pregnancy within the follow-up period.

You may not qualify if:

• Known Müllerian anomalies or uterine fibroids.
• Previous uterine surgery.
• Multiple gestation.
• Chorioamnionitis, placenta previa, or placental abruption.
• Preeclampsia/eclampsia.
• Hepatic or renal dysfunction, uncontrolled diabetes, or systemic disease.
• Peripartum hemoglobin \< 10 g/dL.
• Chronic corticosteroid use or smoking.
• Inability to provide consent.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha Univesity Hospital

Banhā, Qalyubia Governorate, 13512, Egypt

Location

Related Publications (9)

• 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

• Monteagudo A, Carreno C, Timor-Tritsch IE. Saline infusion sonohysterography in nonpregnant women with previous cesarean delivery: the "niche" in the scar. J Ultrasound Med. 2001 Oct;20(10):1105-15. doi: 10.7863/jum.2001.20.10.1105.

  PMID: 11587017 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

• Vikhareva Osser O, Valentin L. Clinical importance of appearance of cesarean hysterotomy scar at transvaginal ultrasonography in nonpregnant women. Obstet Gynecol. 2011 Mar;117(3):525-532. doi: 10.1097/AOG.0b013e318209abf0.

  PMID: 21343754 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. 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

• Antoine C, Meyer JA, Silverstein JS, Alexander J, Oh C, Timor-Tritsch IE. The Impact of Uterine Incision Closure Techniques on Post-cesarean Delivery Niche Formation and Size: Sonohysterographic Examination of Nonpregnant Women. J Ultrasound Med. 2022 Jul;41(7):1763-1771. doi: 10.1002/jum.15859. Epub 2021 Nov 2.

  PMID: 34726789 RESULT

• Tsuji S, Katsura D, Tokoro S, Inatomi A, Nobuta Y, Yoneoka Y, Amano T, Murakami T. Two-layer interrupted versus two-layer continuous sutures for preventing cesarean scar defect: a randomized controlled trial. BMC Pregnancy Childbirth. 2025 Mar 7;25(1):248. doi: 10.1186/s12884-025-07353-1.

  PMID: 40055610 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
• 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 13, 2025
• Primary Completion: June 15, 2025
• Study Completion: December 30, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)