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

NCT ID: NCT07229222

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-13
• Study Completion Date: 2025-12-31

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.

Detailed Description

All primigravidae at or beyond 28 weeks' gestation undergoing primary cesarean section for any indication were assessed for eligibility. All participants provided written informed consent before enrolment. All patients received preoperative antibiotic prophylaxis at induction of anesthesia and postoperative prophylaxis for 24 h. A single intramuscular dose of oxytocin 10 IU was administered during the first 24 h postpartum. After confirming eligibility and obtaining consent, a trained nurse selected an envelope for each patient and revealed the allocation to the operating obstetrician. Patients were blinded to group allocation.

• Study Group: Two-layered simple interrupted suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum.
• Control Group: Double-layered continuous suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum.

The parietal peritoneum was left open in all cases. Hemostasis was ensured, and the number of additional hemostatic sutures was recorded. A braided polyglycolic acid 0-1 suture was used in all cases. All other steps of cesarean section were standardized.

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.

Menstrual history was obtained by an independent obstetrician/gynecologist, documenting spotting days, total bleeding days, amenorrhea, and contraceptive use.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Two-layered simple interrupted suturing of the myometrium

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Saline-infusion Sonohysterography

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Saline-infusion Sonohysterography

Intervention Type: 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.

Interventions

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

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.

Intervention Type: PROCEDURE

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

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.

Intervention Type: PROCEDURE

Saline-infusion Sonohysterography

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdel Latif Ahmed Alnezamy

Lecturer of Obstetrics and Gynecology, Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED ALNEZAMY, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Benha Univesity Hospital

Banhā, Qalyubia Governorate, Egypt

Countries

Egypt

References

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Reference Type: BACKGROUND

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Reference Type: RESULT

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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.

Reference Type: RESULT

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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.

Reference Type: RESULT

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Other Identifiers

RC13-2-2025

Identifier Type: -

Identifier Source: org_study_id