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临床试验/CTRI/2025/02/080641
CTRI/2025/02/080641已完成2/3 期

Injection Calcium Gluconate for prevention of post partum haemorrhage during cesarean delivery: Randomised placebo control trial

Dr Merlyn Joseph1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2025年2月27日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
176
试验地点
1
主要终点
To know the efficacy, side effects of IV Calcium Gluconate for prevention of PPH during caesarean section and to observe for the intraoperative blood loss

研究概览

简要总结

Postpartum haemorrhage can be a traumatic experience for individuals. Postpartum haemorrhage (PPH) is the most common cause of maternal mortality worldwide. It is classically defined as excessive loss of blood with a threshold of 500 ml or more after vaginal delivery or 1000 ml or more after a caesarean section. PPH can happen suddenly and requires prompt medical intervention.The primary cause of PPH is often attributed to uterine atony, which is delineated as inability of the uterus to properly contract after placental delivery. Therefore it is a necessity to avoid uterine atony during caesarean delivery which indeed serves as a crucial step to avoid post partum haemorrhage. Currently for the prophylaxis of PPH we give Oxytocin, Carbetocin and use of second line uterotonics, including Carboprost, Misoprost etc.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Primigravida or multigravida with period of gestation ≥ 37 weeks undergoing caesarean section with singleton pregnancy with vertex presentation.

排除标准

  • all patients with high risk for pph polyhydramnios antepartum hemorrhage preeclampsia grand multipara prolonged labor preterm previous myomectomy history of drug allergy to calcium gluconate history of medical disorders like cardiac, liver, renal disorders intrauterine fetal demise cardiac arrhythmia.

结局指标

主要结局

To know the efficacy, side effects of IV Calcium Gluconate for prevention of PPH during caesarean section and to observe for the intraoperative blood loss

时间窗: To know the efficacy, side effects of IV Calcium Gluconate for prevention of PPH during caesarean section and to observe for the intraoperative blood loss at 3 mins, 6 mins and 10 mins after administration of the drug

次要结局

  • Need for second line of oxytocic(Side effect of Calcium Gluconate)

研究者

发起方
Dr Merlyn Joseph
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Merlyn Joseph

Shri BM Patil Medical College and Research centre

研究点 (1)

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