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临床试验/CTRI/2022/09/046065
CTRI/2022/09/046065尚未招募4 期

comparison of efficacy of misoprostol versus Foley and misoprostol combination in second trimester medical termination of pregnancy

Dr Hanumant V Nipanal1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年9月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
96
试验地点
1
主要终点
Complete expulsion of products of conception

研究概览

简要总结

Abortion is defined asTermination of pregnancy by any means before the fetus is viable. Abortionswill be done up to 24 weeks pregnancy Medical Termination of Pregnancy [MTP]Act, enacted by the Indian parliament came into effect from 1 April 1972 andnew amendment of 2021. Presently MTP can be performed on Medical,Eugenic, Humanitarian and Social grounds, Terminatinga pregnancy in 2nd trimester is a bigger danger to boththe mother and foetus as compared to a first trimester pregnancy. A majority ofthe abortions in second trimester are carried out because of foetalabnormalities and sometimes maternal complications. Out of the differentmethods of termination, medical methods are believed to be safer and moreeffective as compared to the surgical approaches. Intravaginal misoprostol andintracervical Foley catheter are the most preferred methods. Few researchersclaim intravaginal misoprostol whereas others believe intracervical Foleycatheter to be more effective and few researches have speculated that if theboth methods are combined will give best results.

Hence,our study is aimed to compare the efficacy of misoprostol versus combination ofFoley catheter and misoprostol in second trimester medical termination ofpregnancy.**OBJECTIVES:**To Comparethe efficacy of misoprostol versus Foley and misoprostol combination in secondtrimester medical termination of pregnancy.

Datacollection method: Pregnant women attending theOPD of GIMS for second trimester MTP that is 12+1 weeks to 24 weeks ofgestation and who will fulfil inclusion and exclusion criteria were selectedfor the study. Ultrasound examination was used for the date confirmation andtheir eligibility to enter into the study. Selected patients were admitted toobstetrics ward and procedure will be planned. Complete evaluation of each patientwas done at admission. Detailed history as well as clinical findings of medicaland obstetric examination was recorded.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • All cases those who will fulfil indication of Medical Termination of Pregnancy for second trimester up 24 weeks, as per guidelines of MTP Act of 1971 and amended in 2021.

排除标准

  • Scarred uterus
  • Ectopic pregnancy
  • Grand multipara
  • Contraindications to misoprostol and Foleys catheter.

结局指标

主要结局

Complete expulsion of products of conception

时间窗: 24hours

次要结局

  • complications (if any)(48 hours)

研究者

发起方
Dr Hanumant V Nipanal
申办方类型
Other [self]

研究点 (1)

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Methods of abortion in second trimester | 临床试验