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临床试验/CTRI/2025/07/091407
CTRI/2025/07/091407尚未招募不适用

Maternal outcome of insitu epair versus exteriorization of uterine incision during cesarean section. A Randomised control trial

Department of Obstetrics and Gynaecology1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2025年8月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
272
试验地点
1
主要终点
Changes in pulse and blood pressure

研究概览

简要总结

**Introduction:**Different techniques of uterine closure have been practiced in order to reduce morbidity during and after cesarean delivery. The techniques vary depending on both the clinical situation and the preferences of the operator, and mainly due to limited information available concerning the most appropriate surgical technique to adopt. Hence, this study aims to compare the difference between uterine exteriorization versus in situ repair during cesarean section affecting maternal outcome.

Methodology: A total of 272 women undergoing cesarean section will be randomized by computer-generated randomization, and a sequentially numbered, sealed opaque envelope method will be used for allocation in this single-blinded parallel-group randomized controlled trial. Group A (experimental group) will be the patients undergoing uterine exteriorization, and Group B (control group) will be the patients undergoing in-situ uterine repair.

Result: The intraoperative observation would note and compare changes in vitals (pulse, blood pressure), symptoms like pain, nausea, and vomiting, need for additional anaesthetic drugs, and assessment of blood loss between both groups. Also, the post-operative observation would note and compare the need for analgesics, return of bowel activity, surgical site infection, hospital stay, and hemoglobin on day 3 between both groups.

Conclusion: The present study will compare and conclude the effectiveness of uterine exteriorization and in-situ repair of uterine incision on maternal outcome during cesarean section. This will explore the outcome in terms of recovery, hospital stay, bowel activity, need for analgesics, surgical site infection, and level of hemoglobin.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Antenatal term women undergoing cesarean section.

排除标准

  • Diagnosed Placenta accreta spectrum.

结局指标

主要结局

Changes in pulse and blood pressure

时间窗: 1. Intraoperative | 2. Post-operative

次要结局

  • 1. Symptoms like pain, nausea, and vomiting.(2. Need for additional anaesthetic drugs.)

研究者

发起方
Department of Obstetrics and Gynaecology
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Silky Dahiwale

NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital

研究点 (1)

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