Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages

Study Overview
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Brief Summary
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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.

Official Title
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COMPARATIVE STUDY OF EFFECTS BETWEEN LETROZOLE PLUS MISOPROSTOL AND MIFEPRISTONE PLUS MISOPROSTOL IN TERMINATING NON-VIABLE FIRST TRIMESTER PREGNANCIES

Conditions
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Miscarriage

Intervention / Treatment
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* Drug: Mifepristone
* Drug: Letrozole


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA : Women older than 18years who will give consent regarding medical management of missed abortion First trimester pregnancy (gestational age less than equal to 12weeks) with missed abortion confirmed by ultrasonography Hemoglobin level more than 12mg/dl EXCLUSION CRITERIA : Hemodynamically unstable patient 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mifepristone<br>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<br>* Participants with 1st trimester miscarriage will receive for medical termination<br>* Other names: Misoprostol 800 microgram vaginally;|
| Experimental: Letrozole<br>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<br>* Participants with 1st trimester miscarriage will receive for medical termination<br>* Other names: Misoprostol 800 microgram vaginally;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expulsion of product of conception | Mean duration of expulsion since administration of vaginal misoprostol | 24 hours since administration of misoprostol | 
| Requirement of surgical evacuation | Surgical evacuation where complete abortion does not occur | beyond 24 hours since misoprostol administration |