Single-Layer Versus Double-Layer Uterine Closure After Primary Cesarean Section

Summary

This study compares two surgical techniques for closing the uterus after cesarean section: single-layer versus double-layer closure. The primary objective is to determine which technique results in better uterine scar healing, measured by residual myometrial thickness (RMT) and cesarean scar defect (niche) prevalence at 6 weeks and 6 months postoperatively.

BACKGROUND:

Cesarean section is one of the most common surgeries worldwide. After fetal delivery, the uterine incision must be closed by suture. Poor scar healing can lead to niche formation, abnormal bleeding, pelvic pain, dyspareunia, and complications in future pregnancies including uterine rupture and placenta accreta.

INTERVENTION:

Participants are randomized 1:1 to receive either:

* Single-layer closure: one continuous non-locking suture through full myometrial thickness
* Double-layer closure: two successive extra-mucosal non-locking sutures excluding the decidua

ASSESSMENTS:

Transvaginal ultrasound at 6 weeks and 6 months measures RMT and niche presence. Standardized symptom questionnaires assess pelvic pain, spotting, dysmenorrhea, and dyspareunia.

ELIGIBILITY:

Women aged 18-45 years undergoing primary cesarean section with singleton pregnancy at term (gestational age ≥ 37 weeks).

ENROLLMENT: 384 participants (192 per group)

SETTING: Department of Obstetrics and Gynecology, Hedi Chaker University Hospital, Sfax, Tunisia

FOLLOW-UP: 6 months per participant in which the patients attend 2 follow-up visits:

First visit 6 weeks after surgery. Second visit at 6 months after surgery

.And have a pelvic ultrasound at each visit

Conditions

• Cesarean Scar Defect (Isthmococele)
• Pelvic Pain
• Spotting
• Amenorrhea Secondary
• Metrorrhagia

Interventions

PROCEDURE

Double-layer hysterorrhaphy at primary cesarean section

After fetal and placental delivery, the uterine incision is closed in two layers using continuous absorbable suture (polyglactin 910). Layer 1: running suture approximating the full myometrial thickness. Layer 2: continuous imbricating suture reinforcing the first layer and improving hemostasis. Additional reinforcement sutures placed if needed. Aims to optimize uterine scar healing and reduce cesarean scar defect (niche) formation.

PROCEDURE

Single-layer hysterorrhaphy at primary cesarean section

After fetal and placental delivery, the uterine incision is closed in one single layer using a continuous absorbable suture (polyglactin 910) approximating the full myometrial thickness in a running pattern. No second reinforcement layer is performed. Additional reinforcement sutures are placed if needed. This represents the conventional standard technique for uterine closure at cesarean section.

Sponsors & Collaborators

• Hédi Chaker Hospital

  lead OTHER

Principal Investigators

• Derbel Mohamed, Professor · Department of obstetric and gynaecology of Hedi Chaker sfax

• Khanfir Fatma, Professor · Department of obstetric and gynaecology of Hedi Chaker sfax

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2026-01-01

Completion

2026-04-30

Countries

• Tunisia

Study Locations