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Completed

NCT Number: NCT07229222

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Benha Univesity Hospital

Banhā, Qalyubia Governorate, 13512, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Rate of uterine niche formation after primary cesarean section.

    Time frame: At 6 months postpartum

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

Secondary outcomes

  1. Uterine niche measurements

    Time frame: At 6 months postpartum

    Using saline-infusion sonohysterography (2D, sagittal and coronal views),niche depth, length, width, and residual myometrial thickness are to be recorded.

  2. Total operative time.

    Time frame: Intraoperative

    The operation room nurse recorded the time lapse between the skin incision and the end of skin suturing.

  3. The correlation between niche width and menstrual cycle abnormalities.

    Time frame: At 6 months postpartum

    For participants diagnosed with uterine niche, menstrual history was obtained by an independent obstetrician/gynecologist, documenting spotting days, total bleeding days, amenorrhea, and contraceptive use.

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

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

    Active labour in primigravida was identified when the cervical dilatation is equal to or more than 3 cm.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Decidual-Sparing Two-Layered Simple Interrupted Myometrial Suturing With Visceral Peritoneal Closure Reduces Uterine Niche Formation After Primary Cesarean Section: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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