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

NCT ID: NCT05304273

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-05

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Mifepristone

Intervention Type DRUG

Participants with 1st trimester miscarriage will receive for medical termination

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).

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

Participants with 1st trimester miscarriage will receive for medical termination

Interventions

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Mifepristone

Participants with 1st trimester miscarriage will receive for medical termination

Intervention Type DRUG

Letrozole

Participants with 1st trimester miscarriage will receive for medical termination

Intervention Type DRUG

Other Intervention Names

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Misoprostol 800 microgram vaginally Misoprostol 800 microgram vaginally

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Calcutta National Medical College and Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr.Jhuma Biswas

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Calcutta National Medical College and Hospital

Kolkata, West Bengal, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Jhuma Biswas

Role: CONTACT

+91 9433019780

Facility Contacts

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Jhuma Biswas

Role: primary

+91 9433019780

Other Identifiers

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G&O/CNMC-118 dt29.12.2021

Identifier Type: -

Identifier Source: org_study_id

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