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

Calcutta National Medical College and Hospital

Status and phase: Enrolling; Phase 3

Conditions: Miscarriage

Treatments: Drug: Mifepristone; Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT05304273

G&O/CNMC-118 dt29.12.2021

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Mifepristone

Active Comparator group

Description:

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).

Treatment:

Drug: Mifepristone

Letrozole

Experimental group

Description:

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).

Treatment:

Drug: Letrozole