Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages
- Registration Number
- NCT05304273
- Lead Sponsor
- Calcutta National Medical College and Hospital
- Brief Summary
Prospective interventional study where participants with non-viable pregnancy at 1st trimester will be randomized into two arms, one group will receive conventional treatment with oral mifepristone followed by misoprostol vaginally and another group will receive letrozole for three consecutive days followed by misoprostol vaginally in an attempt to terminate the pregnancy medically. Mean duration of induction to expulsion of product of conception and rate of complete abortion will be compared in two groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Letrozole Letrozole Participants with 1st trimester miscarriage will receive 10mg letrozole orally for three consecutive days. This is to be followed by tablet misoprostol 800 micro gm vaginally for expulsion of product of conception (standard care). Mifepristone Mifepristone Participants with 1st trimester miscarriage will receive oral 200mg mifepristone . After 48 hours of mifepristone, 800 micro gm misoprostol will be given vaginally for expulsion of product of conception (standard care).
- Primary Outcome Measures
Name Time Method Expulsion of product of conception 24 hours since administration of misoprostol Mean duration of expulsion since administration of vaginal misoprostol
Requirement of surgical evacuation beyond 24 hours since misoprostol administration Surgical evacuation where complete abortion does not occur
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Calcutta National Medical College and Hospital
🇮🇳Kolkata, West Bengal, India