Mifepristone as a single agent for second trimester termination of pregnancy in women with previous caesarea
- Conditions
- Health Condition 1: O048- (Induced) termination of pregnancywith other and unspecified complications
- Registration Number
- CTRI/2023/06/053424
- Lead Sponsor
- Diksha Malhotra
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
All women with previous caesarean section requiring termination of pregnancy between 14-24 weeks
1) 18 years or older
2) Singleton gestation
3) Late miscarriage/inevitable abortion between 14-20 weeks
4) Pregnancy getting terminated for lethal fetal anomalies/medical or social reasons between 14-24 weeks(under MTP Amendment Act,2021)
5) Intra uterine fetal death (IUFD)/previable premature rupture of membranes(PPROM)between 20-24 weeks
1) Known contraindication to mifepristone(chronic adrenal failure, long term steroid treatment,concurrent anticoagulation therapy,bleeding disorders,inherited porphyrias)
2) Known contraindication to misoprostol(renal impairment,inflammatory bowel disease, pre existing heart disease,unexplained vaginal bleeding,known allergies)
3) Previous myomectomy or nature of scar unknown or previous history of uterine rupture
4) Severe anaemia
5) Evidence of sepsis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of women having successful induction of abortionTimepoint: After 24 hours of completion of regimen
- Secondary Outcome Measures
Name Time Method 1) Induction to abortion time in hours <br/ ><br>2) Rate of complete abortion <br/ ><br>3) Failed abortion rate <br/ ><br>4) Number of women having adverse events <br/ ><br>5) Maternal side effects like vomiting, diarrhoea, shivering, pyrexia <br/ ><br>6) Pregnancy related readmission within 30 daysTimepoint: After 24 hours of completion of regimen