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

September 2, 2023 updated by: Dr.Jhuma Biswas, Calcutta National Medical College and Hospital

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 24 hours since administration of misoprostol
Mean duration of expulsion since administration of vaginal misoprostol
24 hours since administration of misoprostol
Requirement of surgical evacuation
Time Frame: beyond 24 hours since misoprostol administration
Surgical evacuation where complete abortion does not occur
beyond 24 hours since misoprostol administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calcutta National Medical College and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

May 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)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 2, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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