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
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
Dr kratika jha
Postgraduate Institute of Medical Education and Research, Chandigarh
