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

Sponsor

Calcutta National Medical College and Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05304273

Collaborator

(none)

120

Enrollment

Location

Arms

11.9

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Miscarriage	Drug: Mifepristone Drug: Letrozole	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 5, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Expulsion of product of conception [24 hours since administration of misoprostol]
Mean duration of expulsion since administration of vaginal misoprostol
Requirement of surgical evacuation [beyond 24 hours since misoprostol administration]
Surgical evacuation where complete abortion does not occur

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Calcutta National Medical College and Hospital	Kolkata	West Bengal	India	700014

Sponsors and Collaborators

Calcutta National Medical College and Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr.Jhuma Biswas, Associate Professor, Dept. of Obstetrics and Gynecology, Calcutta National Medical College and Hospital, Calcutta National Medical College and Hospital

ClinicalTrials.gov Identifier:

NCT05304273

Other Study ID Numbers: