Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages
Primary Purpose
Miscarriage
Status
Recruiting
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Mifepristone
Letrozole
Sponsored by
About this trial
This is an interventional treatment trial for Miscarriage
Eligibility 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
Sites / Locations
- Calcutta National Medical College and HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mifepristone
Letrozole
Arm 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).
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).
Outcomes
Primary Outcome Measures
Expulsion of product of conception
Mean duration of expulsion since administration of vaginal misoprostol
Requirement of surgical evacuation
Surgical evacuation where complete abortion does not occur
Secondary Outcome Measures
Full Information
NCT ID
NCT05304273
First Posted
March 14, 2022
Last Updated
September 2, 2023
Sponsor
Calcutta National Medical College and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05304273
Brief Title
Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages
Official Title
COMPARATIVE STUDY OF EFFECTS BETWEEN LETROZOLE PLUS MISOPROSTOL AND MIFEPRISTONE PLUS MISOPROSTOL IN TERMINATING NON-VIABLE FIRST TRIMESTER PREGNANCIES
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Calcutta National Medical College and Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Miscarriage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mifepristone
Arm Type
Active Comparator
Arm 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).
Arm Title
Letrozole
Arm Type
Experimental
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Other Intervention Name(s)
Misoprostol 800 microgram vaginally
Intervention Description
Participants with 1st trimester miscarriage will receive for medical termination
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Misoprostol 800 microgram vaginally
Intervention Description
Participants with 1st trimester miscarriage will receive for medical termination
Primary Outcome Measure Information:
Title
Expulsion of product of conception
Description
Mean duration of expulsion since administration of vaginal misoprostol
Time Frame
24 hours since administration of misoprostol
Title
Requirement of surgical evacuation
Description
Surgical evacuation where complete abortion does not occur
Time Frame
beyond 24 hours since misoprostol administration
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jhuma Biswas
Phone
+91 9433019780
Email
drjhumabiswas78@gmail.com
Facility Information:
Facility Name
Calcutta National Medical College and Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700014
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jhuma Biswas
Phone
+91 9433019780
Email
drjhumabiswas78@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages
We'll reach out to this number within 24 hrs