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临床试验/CTRI/2025/11/097831
CTRI/2025/11/097831尚未招募3 期

Early Oral Feeding Versus Conventional Late Oral Feeding For Postoperative Management Of Caesarean Section Performed Under Regional Anaesthesia

Nadim Ul Haque1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年12月2日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
400
试验地点
1
主要终点
pain score, return of Intestinal Peristaltic Sound, nausea and vomiting

研究概览

简要总结

Women who had Caesarean section under spinal anaesthesia with uneventful operative procedure were included in study . The population did not have any major medical or surgical comorbidities/complications prior to or during pregnancy, and labour. They will fulfill predefined inclusion and exclusion criteria , and they will criteria included in the proposed study .We will conduct a prospective, randomized controlled trial[open label] to compare the effects of  early oral  feeding to late oral feeding   during the post caesarean section period . The statistical analysis will enable us to draw meaningful conclusions from the data, specifically regarding the efficacy of early oral feeding compare to late oral feeding during post caesarean section period.  Feeding and hydration methods are clinically very relevant because it greatly affects physical and psychological wellbeing of mothers. At early oral feeding enhance mobilization of mothers in postoperative period it is likely to enhance  early breast feeding of neonates.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • Singleton pregnancy, term gestation 37- 42 weeks, low risk status.

排除标准

  • High risk pregnancies including those with preexisting medical conditions , previous ceaseran delivery, or pregnancies requiring induction of labor.

结局指标

主要结局

pain score, return of Intestinal Peristaltic Sound, nausea and vomiting

时间窗: Date and time of Operation is considered as Day-1, 0 (zero) hour; Assessment will be done at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours (Day1 completed), and then Day 2, Day 3, Day 4, Day 5, Day 6 , Day 7 of operation; and on the day of Discharge.

次要结局

  • Surgical site infection, return of appetite, early ambulation, initiation of breastfeeding(Date & time of Operation is considered as Day-1, 0 (zero) hour; Assessment will be done at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours (Day1 completed), & then Day 2, Day 3, Day 4, Day 5, Day 6 , Day 7 of operation; & on the day of Discharge.)

研究者

发起方
Nadim Ul Haque
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nadim Ul Haque

IPGMER and SSKM

研究点 (1)

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