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临床试验/CTRI/2025/10/096250
CTRI/2025/10/096250尚未招募1 期

Intrauterine Misoprostol Versus per Rectal Misoprostol During Cesarean Section to Prevent Primary Postpartum Hemorrhage-- A Comparative analysis

Madhumanti Banerjee1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
1 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 efficacy and safety of intrauterine misoprostol in preventing primary post partum hemorrhage during cesarean section as compared to per rectal misoprostol during cesarean section

研究概览

简要总结

A study where we compare the effectiveness of intrauterine misoprostol as compared to per rectal misoprostol during cesarean section in controlling primary post partum hemorrhage. The patients fitting the inclusion criteria will be subjected to the study after proper consent and the effectiveness will be measured with the help of a formula based primarily on the basis of difference in the hematocrit and other factors like mop soakage and suction drain content.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Women bearing full term singleton healthy living fetus with gestational age more than 37 weeks either confirmed from first date of last menstrual period or first trimester ultrasound scan.

排除标准

  • Women with pre operative hemoglobin less than 9gm/dl , concomittant medical disorders, more than two previous cesarean section, allergic to prostaglandin, with higher risk of post partum hemorrhage ( abnormal placentation, twin pregnancy, previous history of uterine atony or PPH, polyhydramnios,uterine fibroids ) , women in whom cesarean section lasts for more than 90 minutes.

结局指标

主要结局

To study efficacy and safety of intrauterine misoprostol in preventing primary post partum hemorrhage during cesarean section as compared to per rectal misoprostol during cesarean section

时间窗: 24hours

次要结局

  • 1) to compare use of additional uterotonics following intrauterine misoprostol administration(2) to compare blood transfusion following intrauterine misoprostol administration)

研究者

发起方
Madhumanti Banerjee
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Madhumanti Banerjee

MIDNAPORE MEDICAL COLLEGE AND HOSPITAL

研究点 (1)

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