临床试验/CTRI/2026/02/104560

CTRI/2026/02/104560尚未招募4 期

Comparison of spinal versus combined spinal-epidural anaesthesia on the incidence of postpartum blues in patients undergoing caesarean delivery: a randomized controlled trial

AIIMS New Delhi1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2026年3月11日最近更新: 2026年2月24日

适应症

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 120
试验地点: 1
主要终点: Incidence of maternal blues on POD-3 using Edinburgh Postnatal Depression Scale (EPDS) in women undergoing caesarean deliveries under SA versus CSE

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

There is a growing need to understand whether optimizing intraoperative and postoperative anesthetic care can influence not only physical recovery but also maternal mental health during the vulnerable puerperium.There are studies on post partum blues but effect of using different models of anesthesia on postpartum blues is not examined until dayby scientific community in Indian population. This study aims to address the lacunae.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 45.00 Year(s)（—）
性别: Female

入选标准

•Women aged between 18 – 40 years, undergoing caesarean delivery (Category III & IV LSCS) American Society of Anaesthesiologists (ASA) physical status I–II Able to understand and complete study questionnaires (e.g. literate in local language).

排除标准

•Pre-existing psychiatric illness or current use of antidepressant or anxiolytic medication Contraindication to neuraxial anaesthesia (e.g. coagulopathy, infection at puncture site, severe spinal deformity) Severe obstetric complications (e.g. pre-eclampsia with severe features, eclampsia, HELLP syndrome) Multiple gestation Advanced cardiac disease Unwillingness to receive an epidural cathete (for the CSE group, if randomized).

结局指标

主要结局

Incidence of maternal blues on POD-3 using Edinburgh Postnatal Depression Scale (EPDS) in women undergoing caesarean deliveries under SA versus CSE

时间窗: Assessed on post operative day 3

次要结局

Severity of maternal blues using EPDS between SA and CSE in women undergoing caesarean deliveries(Assessed on Post operative day 3)
Incidence of postpartum blues using EDPS score
Post-operative pain scores in both groups using NRS score(Assessed at 6 hours, 24 hours, 48 hours, 72 hours after surgery)

研究者

发起方

AIIMS New Delhi

申办方类型

Government medical college

责任方

Principal Investigator

主要研究者

Amal Razik

AIIMS New Delhi

研究点 (1)

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