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OpenTrials
Completed

NCT Number: NCT05304273

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

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.

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Key information

Conditions

Miscarriage Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Calcutta National Medical College and Hospital

Kolkata, West Bengal, 700014, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone

Drug

Participants with 1st trimester miscarriage will receive for medical termination

Other names: Misoprostol 800 microgram vaginally

letrozole

Drug

Participants with 1st trimester miscarriage will receive for medical termination

Other names: Misoprostol 800 microgram vaginally

Primary outcomes

  1. Expulsion of product of conception

    Time frame: 24 hours since administration of misoprostol

    Mean duration of expulsion since administration of vaginal misoprostol

  2. Requirement of surgical evacuation

    Time frame: beyond 24 hours since misoprostol administration

    Surgical evacuation where complete abortion does not occur

Sponsors and collaborators

Lead sponsor

Calcutta National Medical College and Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2022
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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