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
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Miscarriage

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