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NCT05304273 Clinical Trial

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

Miscarriage Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05304273
Other study ID # G&O/CNMC-118 dt29.12.2021
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 5, 2022
Est. completion date May 2024

Study information
Verified date September 2023
Source Calcutta National Medical College and Hospital
Contact Jhuma Biswas
Phone +91 9433019780
Email drjhumabiswas78@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date May 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mifepristone
Participants with 1st trimester miscarriage will receive for medical termination
• Letrozole
Participants with 1st trimester miscarriage will receive for medical termination

Locations
Country Name City State
India Calcutta National Medical College and Hospital Kolkata West Bengal

Sponsors (1)
Lead Sponsor Collaborator
Calcutta National Medical College and Hospital

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Expulsion of product of conception Mean duration of expulsion since administration of vaginal misoprostol 24 hours since administration of misoprostol
Primary Requirement of surgical evacuation Surgical evacuation where complete abortion does not occur beyond 24 hours since misoprostol administration
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