Uterine Scar Resection During Repeat Cesarean Delivery in a Simple Modification to Prevent Uterine Niche Formation: Results of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Rate of uterine niche formation after repeated cesarean section
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Eligible women were randomized (1:1) using a computer-generated sequence in blocks of 10. Allocation was concealed in sequentially numbered, opaque, sealed envelopes opened by a trained nurse after consent. Obstetricians were informed of assignment, while participants , investigator, and ultrasound assessors remained blinded.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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.
研究组 & 干预措施
uterine scar resection
During repeat cesarean section, the previous uterine cesarean section scar was resected.
干预措施: Repeated cesarean section with previous uterine cesarean section scar resection (Procedure)
uterine scar resection
During repeat cesarean section, the previous uterine cesarean section scar was resected.
干预措施: Saline-infusion Sonohysterography (Diagnostic Test)
Non scar resection
Standard repeat cesarean section without previous uterine cesarean section scar resection.
干预措施: Repeated cesarean section without uterine scar resection (Procedure)
Non scar resection
Standard repeat cesarean section without previous uterine cesarean section scar resection.
干预措施: Saline-infusion Sonohysterography (Diagnostic Test)
结局指标
主要结局
Rate of uterine niche formation after repeated cesarean section
时间窗: 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.
次要结局
- Menstrual characteristics among participants with uterine niche(At 6 months postpartum)
- Total operative time.(Intraoperative)
- The mean estimated intraoperative blood loss.(Intraoperative)
- The number of additional hemostatic sutures needed.(immediately postoperative)
- Uterine niche measurments(At 6 months postpartum)
研究者
Ahmed Abdel Latif Ahmed Alnezamy
Lecturer of Obstetrics and Gynecology, Faculty of Medicine
Benha University