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Completed

NCT Number: NCT07228858

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

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.

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Key information

Conditions

Cesarean Section Complications Scar Niche Scarred Uterus

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

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Repeated cesarean section with previous uterine cesarean section scar resection

Procedure

After creating the bladder flap, the uterus was incised 5 mm cranial to the scar and extended laterally 5 mm beyond its ends. After delivery of the newborn, a 1 cm segment of uterine wall (5 mm above and 5 mm 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 with visceral peritoneum closure.

Repeated cesarean section without uterine scar resection

Procedure

Standard repeat cesarean section without scar resection, followed by double-layer continuous myometrial closure including decidua with visceral peritoneum closure.

Saline-infusion Sonohysterography

Diagnostic Test

At 6 months postpartum, all participants are to be 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 is defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness are to be recorded.

Primary outcomes

  1. Rate of uterine niche formation after repeated cesarean section

    Time frame: At 6 months postpartum

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

Secondary outcomes

  1. Total operative time.

    Time frame: Intraoperative

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

  2. The mean estimated intraoperative blood loss.

    Time frame: Intraoperative

    The estimated intraoperative blood loss was evaluated by weighting all surgical sponges, swabs, and drapes before and after use. Using this formula: Blood Loss (mL) = (Wet weight - Dry weight in grams) = mL of blood lost then add this to the volume of blood collected in suction canisters and subtract any irrigation or amniotic fluid.

  3. The number of additional hemostatic sutures needed.

    Time frame: immediately postoperative

    The the obstetrician who performed the procedure recorded this in the participant file.

  4. Uterine niche measurments

    Time frame: At 6 months postpartum

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

  5. Menstrual characteristics among participants with uterine niche

    Time frame: At 6 months postpartum

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

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Uterine Scar Resection During Repeat Cesarean Delivery in a Simple Modification to Prevent Uterine Niche Formation: Results of a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2025
Registry last updated
Dec 29, 2025

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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