跳至主要内容
临床试验/CTRI/2024/10/075280
CTRI/2024/10/075280尚未招募3 期

A randomized control study to determine the efficacy of preoperative per rectal misoprostol in reducing blood loss in LSCS

DR SRINIDHI P M BHAT1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年10月28日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
To study the effect of preoperative per rectal misoprostol in reducing intraoperative blood loss in lower segment cesarean section.

研究概览

简要总结

This will be a randomized control trial spanning over 18 months, conducted in KIMS HUBLI. A total of 200 women meeting the inclusion criteria with written informed consent will be taken up for the study. Detailed history regarding gravida,  parity, gestational age, presence of risk for PPH and other comorbidities and the indication for cesarean will be noted . Complete clinical and laboratory evaluation will be done. Eligible women will be randomized into 2 groups. Women in study group will receive 800mcg misoprostol per rectally  immediately after spinal anesthesia. Caesarean delivery will be performed under spinal anesthesia by senior obstetricians who will be blind to allocation. 10 IU Oxytocin im will be administered intraoperative to both the groups as per the standard AMTSL practice .

Estimation of blood loss will be  started after uterine incision. During the operation an isolated suction will be  used for evacuation of amniotic fluid through a small incision over the uterus, and another one will be used for collection of blood. A dedicated assistant will be  responsible for collection of blood and amniotic fluid in 2 separate suction sets, and for weighing surgical towels before and after operation. Gravimetric method will be used to determine the blood loss i.e the weight difference of 1gm between pre operative mops and post operative mops will be taken as 1 ml of blood loss. The collected blood in suction bottle would be added to the blood in clots and swabs. Blood loss will be calculated and compared in both. Preoperative and post operative hemoglobin and hematocrit values will be used to calculate the overall blood loss caused by the procedure.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Consenting women undergoing lower segment cesarean section in KIMS during study period.

排除标准

  • Women known to have hypersensitivity to prostaglandin.
  • Medical contraindications for prostaglandin.
  • Women not consenting for trial.

结局指标

主要结局

To study the effect of preoperative per rectal misoprostol in reducing intraoperative blood loss in lower segment cesarean section.

时间窗: immediate post operative.48 hours post operatively

次要结局

  • To determine the use of pre operative misoprostol in reducing the incidence of PPH and there by reducing maternal mortality and morbidity.(2HRS AFTER LSCS)

研究者

发起方
DR SRINIDHI P M BHAT
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Srinidhi Bhat

Karnataka institute of medical science

研究点 (1)

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