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To compare Mifepristone and vaginal misoprosotol combination with vaginal misoprostol alone in the management of missed abortion in first trimester.

A comparative study of Mifepristone and Vaginal misoprostol Versus Vaginal misoprostol alone in the management of First trimester Missed miscarriage - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078099
Enrollment
62
Registered
2024-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: O021- Missed abortion

Interventions

Intervention1: Misoprostol alone: Misoprostol 400mcg BD per vaginal for 1 day alone Control Intervention1: Mifepristone, Misoprostol: Mifepristone 200 mg OD PO for 1 day Misoprostol 400 mcg BD Per v

Sponsors

Sai Raja Nandini Kilari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women with scan finding of missed miscarriage the criteria include any one of these: Intrauterine gestation with gestational sac - 20 mm with no evidence of an embryo/yolk sac. Intrauterine gestation with CRL-6 mm without cardiac activity. Intrauterine gestation with gestational sac -20 mm/CRL -6 mm with no growth in 7 days. Radiological signs of abnormal pregnancy—irregular sac/debris within the gestational sac. Conscious and co-operative patients. Patients willing to give consent.

Exclusion criteria

Exclusion criteria: Women who opted for alternative methods of miscarriage management (expectant or surgical). Women with Missed miscarriages in second trimester. Induced abortions. Diagnosis of Incomplete miscarriage. Hemodynamic instability. Life threatening bleeding. Contraindications to Mifepristone or Misoprostol. Patients not willing to give consent.

Design outcomes

Primary

MeasureTime frame
To investigate whether treatment with mifepristone plus vaginal misoprostol would result in a higher rate of successful medical management of missed miscarriage compared with vaginal misoprostol alone.Timepoint: 1 assessment after 24 hours 2 assessment after 48 hours

Secondary

MeasureTime frame
To assess the efficacy and safety of combination of Mifepristone and misoprostol Vs efficacy and safety of misoprostol alone. Timepoint: 1 assessment after 24 hours 2 assessment after 48 hours

Countries

India

Contacts

Public ContactSai Raja Nandini Kilari

Dr MGR educational and research institute Deemed to be university

drgganitha77@gmail.com9442032623

Outcome results

None listed

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