跳至主要内容
临床试验/CTRI/2025/10/096393
CTRI/2025/10/096393尚未招募2/3 期

A randomized controlled, open-label, non-inferiority trial to compare the efficacy and safety of low-dose oxytocin versus standard-dose oxytocin in achieving adequate uterine tone and preventing postpartum haemorrhage during scheduled cesarean deliveries

Postgraduate Institute of Medical Education and Research Chandigarh1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
adequate uterine tone on likert scale more than 2 at 5 minutes post oxytocin administration

研究概览

简要总结

Postpartum haemorrhage (PPH) is a leading cause of maternal morbidity and mortality,

particularly after cesarean deliveries. Oxytocin is the first-line uterotonic recommended

globally to prevent uterine atony and PPH. Historically, high prophylactic doses were used,

but newer evidence suggests that lower doses may be equally effective with fewer adverse

effects. Guidelines such as ERAS 2025 promote individualized, lower-dose regimens to

minimize side effects like hypotension and tachycardia. However, there is variability in

practice, and optimal dosing in low-risk scheduled cesareans remains unclear, especially in

Indian settings, necessitating further evaluation through randomized clinical trial

This study will provide robust evidence on whether a low-dose oxytocin regimen is non-

inferior to the standard dose in achieving adequate uterine tone during scheduled cesarean

deliveries. It will also assess the impact on intraoperative blood loss, requirement for

additional uterotonics, and maternal hemodynamic stability. By directly comparing both

regimens under a randomized, controlled, real-world clinical setting, the findings will help

refine oxytocin dosing protocols. The study’s outcomes could support adoption of lower

prophylactic doses, improving safety profiles while maintaining efficacy, and may

contribute to national and international guideline updates for PPH prevention in cesarean

deliveries.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and 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 18–45 years
  • Singleton pregnancy
  • Scheduled cesarean delivery at 37–40 weeks
  • Regional anesthesia planned
  • Willing to participate and provide written informed consent.

排除标准

  • refusal to consent asa physical status more than 3 conditions increasing risk of uterine atony cardiac, hepatic,autoimmune,renal disorders uncontrolled hypertension, diabetes contraindications to regional anaesthesia cesarean performed during labor.

结局指标

主要结局

adequate uterine tone on likert scale more than 2 at 5 minutes post oxytocin administration

时间窗: 5 min

次要结局

  • Total intraoperative blood loss(2. Change in hematocrit at 24 hours)

研究者

发起方
Postgraduate Institute of Medical Education and Research Chandigarh
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr kratika jha

Postgraduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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