NCT05304273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 5, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

March 14, 2022

Last Update Submit

March 28, 2026

Conditions

Miscarriage

Outcome Measures

Primary Outcomes (2)

  • Expulsion of product of conception

    Mean duration of expulsion since administration of vaginal misoprostol

    24 hours since administration of misoprostol

  • Requirement of surgical evacuation

    Surgical evacuation where complete abortion does not occur

    beyond 24 hours since misoprostol administration

Study Arms (2)

Mifepristone

ACTIVE COMPARATOR

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

Letrozole

EXPERIMENTAL

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

Interventions

MifepristoneDRUG

Participants with 1st trimester miscarriage will receive for medical termination

Also known as: Misoprostol 800 microgram vaginally
Mifepristone
LetrozoleDRUG

Participants with 1st trimester miscarriage will receive for medical termination

Also known as: Misoprostol 800 microgram vaginally
Letrozole

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Calcutta National Medical College and Hospital

Kolkata, West Bengal, 700014, India

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

MifepristoneLetrozole

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Dept. of Obstetrics and Gynecology, Calcutta National Medical College and Hospital

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 31, 2022

Study Start

May 5, 2022

Primary Completion

July 26, 2024

Study Completion

October 1, 2024

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations

IN(1)