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临床试验/CTRI/2025/10/096663
CTRI/2025/10/096663尚未招募Phase 3 4

A Open labelled Randomised controlled trial to compare the efficacy of Carbetocin and Oxytocin in preventing post partum haemorrhage in uncomplicated elective caesarean sections at a tertiary care centre in Telangana

ALL INDIA INSTITUTE OF MEDICAL SCIENCESBIBINAGAR1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年11月16日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
To estimate the amount of intra operative blood loss in uncomplicated elective caesarean sections

研究概览

简要总结

open-label randomized controlled trial aims to compare the efficacy of carbetocin versus oxytocin in preventing postpartum hemorrhage (PPH) following uncomplicated elective caesarean sections. The study will be conducted over 18 months at AIIMS Bibinagar, involving 200 pregnant women randomly assigned to receive either carbetocin or oxytocin during surgery. Intraoperative blood loss will be measured using mop weight and suction canister volume, while postpartum blood loss will be visually estimated over 24 hours. Secondary outcomes include the need for additional uterotonics, surgical interventions, blood transfusions, and adverse drug effects. Participants will be selected based on strict inclusion and exclusion criteria to ensure uniformity. Randomization will be done using permuted blocks and allocation concealed in sealed envelopes. Hemoglobin levels will be assessed pre- and post-operatively to evaluate blood loss impact. Data will be analyzed using Stata 18, applying appropriate statistical tests for continuous and categorical variables. The study seeks to generate evidence on which uterotonic agent offers superior efficacy and safety in PPH prevention. Results will inform clinical practice in obstetric care during cesarean deliveries.

研究设计

研究类型
Interventional

入排标准

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

入选标准

  • Pregnant women 37 weeks of gestation Age 18 to 45 years Uncomplicated elective caesarean section Singleton pregnancy.

排除标准

  • 未提供

结局指标

主要结局

To estimate the amount of intra operative blood loss in uncomplicated elective caesarean sections

时间窗: To estimate the amount of intra operative blood loss after placental delivery in uncomplicated elective caesarean sections

次要结局

  • Estimation of postpartum blood loss within 24 hours following uncomplicated elective caesarean sections

研究者

发起方
ALL INDIA INSTITUTE OF MEDICAL SCIENCESBIBINAGAR
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

PALATI BHARGAVI

AIIMS BIBINAGAR

研究点 (1)

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