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

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

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 Overview

• Status: Completed
• Conditions: Miscarriage
• Intervention / Treatment: Drug: Mifepristone; Drug: Letrozole

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • West Bengal
    • Kolkata, West Bengal, India, 700014
      • Calcutta National Medical College and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 12g/dl. To improve sample size later hemoglobin level 10 gm% or more was considered and EC was informed on 5.10.2022 about this minor change in the study design.

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Misoprostol 800 microgram vaginally
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: Misoprostol 800 microgram vaginally

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Calcutta National Medical College and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Actual): July 26, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Abortion, Spontaneous; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Nitriles; Estrenes; Estranes; Triazoles; Letrozole; Mifepristone
• Other Study ID Numbers: G&O/CNMC-118 dt29.12.2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No