Mifepristone as a single agent for second trimester termination of pregnancy in women with previous caesarean

Mifepristone as a single agent versus mifepristone followed by misoprostol for second trimester termination of pregnancy in women with previous caesarean

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053424

Enrollment

Registered

2023-06-01

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O048- (Induced) termination of pregnancywith other and unspecified complications

Interventions

Intervention1: Mifepristone only: Tab Mifepristone 200mg orally given 8 hourly for 48 hours Control Intervention1: Mifepristone followed by misoprostol: Tab Mifepristone 200mg orally.After 48 hours of

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Proportion of women having successful induction of abortionTimepoint: After 24 hours of completion of regimen	—

Secondary

Measure	Time frame
1) Induction to abortion time in hours 2) Rate of complete abortion 3) Failed abortion rate 4) Number of women having adverse events 5) Maternal side effects like vomiting, diarrhoea, shivering, pyrexia 6) Pregnancy related readmission within 30 daysTimepoint: After 24 hours of completion of regimen	—

Countries

India

Contacts

Public ContactDr Diksha Malhotra

UCMS and GTB Hospital, Delhi

drpriyabhanu@gmail.com9650514269

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026