| CTRI Number |
CTRI/2024/07/070965 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Mifepristone and Letrozole in medical termination of pregnancy. |
|
Scientific Title of Study
|
Comparison between Letrozole and Mifepristone as pre-treatment in medical management of early pregnancy termination: a prospective open-label randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanchari Debnath |
| Designation |
Post graduate resident |
| Affiliation |
AGARTALA GOVERNMENT MEDICAL COLLEGE AND GBP HOSPITAL. |
| Address |
Department of Obstetrics and Gynaecology, AGMC and GBP Hospital, Kunjaban, Agartala.
North Tripura
TRIPURA
799006
India |
| Phone |
8837364512 |
| Fax |
|
| Email |
dsanchari97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jahar Lal Baidya |
| Designation |
Professor |
| Affiliation |
AGARTALA GOVERNMENT MEDICAL COLLEGE AND GBP HOSPITAL. |
| Address |
Department of Obstetrics and Gynaecology, AGMC and GBP Hospital, Kunjaban, Agartala.
West Tripura
TRIPURA
799006
India |
| Phone |
9436127555 |
| Fax |
|
| Email |
iamjlbaidya@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debasis Ray |
| Designation |
Professor |
| Affiliation |
AGARTALA GOVERNMENT MEDICAL COLLEGE AND GBP HOSPITAL. |
| Address |
Department of Pharmacology, AGMC and GBP Hospital, Kunjaban, Agartala.
West Tripura
TRIPURA
799006
India |
| Phone |
9436125100 |
| Fax |
|
| Email |
contactdebasisray@gmail.com |
|
|
Source of Monetary or Material Support
|
| Agartala Government Medical College and GBP Hospital, Kunjaban, Agartala, Tripura, PIN 799006, India |
|
|
Primary Sponsor
|
| Name |
Sanchari Debnath |
| Address |
Department of Obstetrics and Gynaecology, AGMC and GBP Hospital, Kunjaban, Agartala, Tripura, PIN - 799006, India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanchari Debnath |
Agartala Government Medical College and GBP Hospital, Kunjaban, Agartala, Tripura, PIN - 799006 |
Dept of Obstetrics and Gynaecology,AGMC and GBP Hospital,Kunjaban,Agartala.
West Tripura
TRIPURA |
8837364512
dsanchari97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Clinical Studies Ref. No. F.4(6-13)/AGMC/Medical Education/IEC Approval/2022/7002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O08||Pregnancy with abortive outcome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Letrozole |
Tablet Letrozole will be given 10 mg once daily per orally for 3 days followed by Tab Misoprostol 800 mcg per vaginally on Day 3 |
| Comparator Agent |
Mifepristone |
Tab Mifepristone will given 200 mg once stat dose per orally followed by Tab Misoprostol 800 mcg per vaginally on Day 3 that is, 48 hours later. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Aged ≥18 years and planned for first trimester missed miscarriage with or without vaginal bleeding at 6-9 complete weeks of gestation
2. With a singleton pregnancy.
3. Who agreed to participate in the trial volunterally.
4. Who had no contraindications for medical abortion. |
|
| ExclusionCriteria |
| Details |
1.Incomplete or invitable miscarriage defined by the clinical finding of an open cervix with bleeding
2.suspected ectopic pregnancy
3.history of heart liver or kidney disease or adrenal insufficiency abnormal uterine lessons such as adenomyosis fibroid or congenital malformations or intra uterine adhesion
4.pregnancy with an intra uterine contraceptive device in situ
5.history of coagulataory dysfunction or intake of anticoagulant drugs
6.hemoglobin level of less than 9.5 gram |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete evacuation of conceptus
|
17 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time interval between consumption of medication and expulsion of product of conception |
17 days |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Miscarriage is a common early pregnancy complication that occurs in 15% to 20% of all clinical pregnancies, and the majority occur in the first trimester. According to FIGO guideline, the typical dosage of misoprostol for the medical management of first trimester miscarriage is 800 microgram vaginally or 600 microgram sublingually 3 hours apart for 2 doses. Misoprostol is a synthetic analogue of naturally occurring prostaglandin E1 which induces abortion by stimulating the myometrium and cause cervical ripening and dilatation. Misoprostol has also been used in conjunction with other medications such as Mifepristone to boost success rates up to 95%. Mifepristone in low dose, 200 mg single per oral dose, works by antagonizing progesterone hormone which is the main hormone for pregnancy continuation. Letrozole is an oral aromatase inhibitor that can prevent the production of estrogen. It has been found to be effective in the medical termination of pregnancy when coupled with misoprostol. After extensive literature search, very few studies could be found which has compared the efficacy of letrozole v/s mifepristone as pretreatment for medical management of early trimester of pregnancy termination as well no such studies could be found from this part of country. Considering the above fact, the present study has been planned to compare the efficacy between Letrozole pretreatment and Mifepristone pre treatment following Misoprostol in early termination of pregnancy for complete evacuation in medical method. Till now I have recruited 40 cases. |