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临床试验/NCT07229222
NCT07229222进行中(未招募)不适用

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

Benha University1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2025年2月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
380
试验地点
1
主要终点
Rate of uterine niche formation after primary cesarean section.

研究概览

简要总结

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.

详细描述

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.

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)

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

  • •Acceptance to participate and willingness to attend follow-up for 6 months postpartum.
  • •No plans for pregnancy within the follow-up period.

排除标准

  • •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.

研究组 & 干预措施

Two-layered simple interrupted suturing of the myometrium

Active Comparator

Two-layered simple interrupted suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum.

干预措施: Primary Cesarean Section with two-layered simple interrupted suturing of the myometrium (Procedure)

Two-layered simple interrupted suturing of the myometrium

Active Comparator

Two-layered simple interrupted suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum.

干预措施: Saline-infusion Sonohysterography (Diagnostic Test)

Double-layered continuous suturing of the myometrium.

Active Comparator

Double-layered continuous suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum.

干预措施: Primary Cesarean Section with double-layered continuous suturing of the myometrium (Procedure)

Double-layered continuous suturing of the myometrium.

Active Comparator

Double-layered continuous suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum.

干预措施: Saline-infusion Sonohysterography (Diagnostic Test)

结局指标

主要结局

Rate of uterine niche formation after primary cesarean section.

时间窗: 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.

Rate of uterine niche formation after primary cesarean section.

时间窗: 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.

次要结局

  • Uterine niche measurements(At 6 months postpartum)
  • Total operative time.(Intraoperative)
  • The correlation between niche width and menstrual cycle abnormalities.(At 6 months postpartum)
  • Uterine niche measurements(At 6 months postpartum)
  • Total operative time.(Intraoperative)
  • The correlation between niche width and menstrual cycle abnormalities.(At 6 months postpartum)
  • The association between active labour at the time of cesarean and niche formation.(Cervical dilatation was evaluated immediately preoperative, while the association was evaluated at 6 months postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Abdel Latif Ahmed Alnezamy

Lecturer of Obstetrics and Gynecology, Faculty of Medicine

Benha University

研究点 (1)

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