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临床试验/CTRI/2025/05/087002
CTRI/2025/05/087002尚未招募不适用

Effect of prophylactic intravenous calcium gluconate administration on blood loss in women undergoing cesarean section with risk factor for postpartum hemorrhage - a randomized controlled trial

JIPMER Intramural Research fund1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
180
试验地点
1
主要终点
To compare the effect of intravenous calcium gluconate with placebo on reduction of intrapartum blood loss in pregnant women posted for cesarean section with risk factor of postpartum hemorrhage.

研究概览

简要总结

This study is a randomized, double blinded, placebo controlled trial accessing the effectiveness of calcium gluconate in reducing blood loss in during cesarean section. The main purpose of this study is to whether giving intravenous calcium gluconate will reduce postpartum bleeding in high-risk pregnancy like, twins, previous cesarean section, obese patients, etc. As calcium gluconate is readily available, cheap and economic, using it for the management of postpartum bleeding will be very effective. Similar studies have been done in normal healthy pregnant women and found to show positive results. So, we have extended it the next level, trying to evaluate its effect in high-risk pregnancy.  The primary objective of this study is to estimate blood loss and secondary outcomes are to compare preoperative and postoperative ionized calcium levels and hemoglobin level by doing a venous blood gas analysis, accessing the uterine tone and monitoring changes in blood pressures and heart rate. The proposed hypothesis is that intravenous calcium gluconate is effective in reducing blood loss in women posted for cesarean section with risk factor for postpartum hemorrhage.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • •Age 18 years and more ASA 2 and 3 Gestational age more than 34 weeks Planned for c-section under spinal anesthesia Pregnant females with high risk for blood loss during c-section like previous cesarean section, twin pregnancy, severe obesity, history of previous postpartum hemorrhage.

排除标准

  • •Pregnant females with heart disease, chronic renal disease, placenta accreta sprectum, pregnant females who are taking calcium channel blockers like nifedipine tablets.

结局指标

主要结局

To compare the effect of intravenous calcium gluconate with placebo on reduction of intrapartum blood loss in pregnant women posted for cesarean section with risk factor of postpartum hemorrhage.

时间窗: At the end of the surgery

次要结局

  • 1.verbal numerical rating scale of uterine tone(2.baseline & postoperative hemoglobin)

研究者

发起方
JIPMER Intramural Research fund
申办方类型
Research institution and hospital

研究点 (1)

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