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

B

Benha University

Status

Completed

Conditions

Cesarean Section Complications
Scar Niche
Scarred Uterus

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07228858
RC9-2-2025

Details and patient eligibility

About

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.

Full description

After eligibility and consenting, multigravida women with ≥1 prior cesarean section scheduled for repeat cesarean section at ≥28 weeks' gestation for any indication were randomized to

  • Study group: During repeat cesarean section, the prior uterine scar was resected. After creating the bladder flap, the uterus was incised 5 mm cranial to the scar and extended laterally 5 mm beyond its ends. Following delivery, a 1 cm segment of uterine wall (5 mm above and 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) and visceral peritoneum closure.
  • Control group: Standard repeat cesarean section without scar resection, followed by identical double-layer and peritoneal closure.

All procedures were performed by obstetricians trained in the protocol. All women received standard preoperative antibiotics, 24-hour postoperative prophylaxis, and 10 units intramuscular oxytocin after delivery.

At 6 months postpartum, all participants will undergo transvaginal ultrasound and saline infusion sonohysterography performed by a blinded, experienced examiner. Sagittal and coronal views willl be obtained, and niche presence, depth, length, width, and residual myometrial thickness are to be recorded.

Obstetricians were informed of assignment, while participants and ultrasound assessor are blinded.

Enrollment

170 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

170 participants in 2 patient groups

uterine scar resection
Active Comparator group
Description:
During repeat cesarean section, the previous uterine cesarean section scar was resected.
Treatment:
Diagnostic Test: Saline-infusion Sonohysterography
Procedure: Repeated cesarean section with previous uterine cesarean section scar resection
Non scar resection
Active Comparator group
Description:
Standard repeat cesarean section without previous uterine cesarean section scar resection.
Treatment:
Diagnostic Test: Saline-infusion Sonohysterography
Procedure: Repeated cesarean section without uterine scar resection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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