Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages
NCT ID: NCT05304273
Last Updated: 2023-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2022-05-05
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Mifepristone
Participants with 1st trimester miscarriage will receive for medical termination
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).
Letrozole
Participants with 1st trimester miscarriage will receive for medical termination
Interventions
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Mifepristone
Participants with 1st trimester miscarriage will receive for medical termination
Letrozole
Participants with 1st trimester miscarriage will receive for medical termination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* First trimester pregnancy (gestational age less than equal to 12weeks) with missed abortion confirmed by ultrasonography
* Hemoglobin level more than 12mg/dl
Exclusion Criteria
* Abnormalities in blood tests including complete blood count (CBC), prothrombin time(PT), internationalised normalized ratio(INR) and fibrinogen
* History or clinical evidence of any thromboembolic impairment or deep venous thrombosis
* Having intra-uterine device
* Present or previous use of corticosteroids
* History of any malignancy
* Existing cardiovascular disease contraindicating misoprostol
18 Years
40 Years
FEMALE
No
Sponsors
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Calcutta National Medical College and Hospital
OTHER_GOV
Responsible Party
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Dr.Jhuma Biswas
Associate Professor, Dept. of Obstetrics and Gynecology, Calcutta National Medical College and Hospital
Locations
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Calcutta National Medical College and Hospital
Kolkata, West Bengal, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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G&O/CNMC-118 dt29.12.2021
Identifier Type: -
Identifier Source: org_study_id
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