Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: 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). |
Drug: Mifepristone
Participants with 1st trimester miscarriage will receive for medical termination
Other Names:
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Experimental: 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). |
Drug: Letrozole
Participants with 1st trimester miscarriage will receive for medical termination
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
INCLUSION CRITERIA :
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Women older than 18years who will give consent regarding medical management of missed abortion
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First trimester pregnancy (gestational age less than equal to 12weeks) with missed abortion confirmed by ultrasonography
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Hemoglobin level more than 12mg/dl
EXCLUSION CRITERIA :
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Hemodynamically unstable patient
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Abnormalities in blood tests including complete blood count (CBC), prothrombin time(PT), internationalised normalized ratio(INR) and fibrinogen
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History or clinical evidence of any thromboembolic impairment or deep venous thrombosis
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Having intra-uterine device
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Present or previous use of corticosteroids
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History of any malignancy
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Existing cardiovascular disease contraindicating misoprostol
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Calcutta National Medical College and Hospital | Kolkata | West Bengal | India | 700014 |
Sponsors and Collaborators
- Calcutta National Medical College and Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- G&O/CNMC-118 dt29.12.2021