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临床试验/CTRI/2024/11/077177
CTRI/2024/11/077177尚未招募3 期

Efficacy and safety of two different doses of vaginal misoprostol for second trimester pregnancy termination in women with previous caesarean section- A Randomised Controlled Study

LOK NAYAK HOSPITAL1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Rate of Sucess of abortion in two groups.

研究概览

简要总结

Second trimester termination of pregnancy approximately accounts for 10-15% of abortions being performed worldwide and its incidence is gradually increasing. The challenges faced by an obstetrician increase as the number of previous caesarean increase as there is no consensus on safe method of termination in these cases. We planned this study to find out the efficacious and safe dose of misoprostol for second trimester termination of pregnancy in women with previous caesarean section as there’s higher chance of complications in scarred uterus compared to unscarred uterus

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • 1.Singleton pregnancy 2.Previous one or two caesarean section 3.Period of gestation:12 week 0 days to 24 weeks 0 days.

排除标准

  • 1.Women with known heart disease 2.Women with low lying placenta.

结局指标

主要结局

Rate of Sucess of abortion in two groups.

时间窗: start and completion of abortion process

Induction abortion interval in hours in both the regimens.

时间窗: start and completion of abortion process

Completeness of Abortion (need for surgical evacuation)- Percentage of cases requiring surgical evacuation or curettage due to retained products of conception in the two groups.

时间窗: start and completion of abortion process

次要结局

  • 1.Incidence of side effects related to misoprostol (nausea, vomiting).(2.Amount of blood loss (in ml): Amount of blood loss will be compared in both arms by using the pictorial method.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Puneet Kaur

post graduate student

研究点 (1)

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