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

Calcutta National Medical College and Hospital120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Miscarriage

Interventions

MifepristoneDRUG

Participants with 1st trimester miscarriage will receive for medical termination

LetrozoleDRUG

Participants with 1st trimester miscarriage will receive for medical termination

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Calcutta National Medical College and Hospital

Kolkata, West Bengal, India

RECRUITING

Outcomes

Primary Outcomes

Expulsion of product of conception

Mean duration of expulsion since administration of vaginal misoprostol

Time frame: 24 hours since administration of misoprostol

Requirement of surgical evacuation

Surgical evacuation where complete abortion does not occur

Time frame: beyond 24 hours since misoprostol administration

Central Contacts

Jhuma Biswas

CONTACT

+91 9433019780 drjhumabiswas78@gmail.com

Data from ClinicalTrials.gov

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