| CTRI Number |
CTRI/2026/04/108686 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
19/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of letrozole vs mifepristone in second trimester miscarriages |
|
Scientific Title of Study
|
Comparison of letrozole vs mifepristone pretreatment with misoprostol in second trimester abortion induction : A RCT |
| Trial Acronym |
RCT - Randomised control trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Yamini Gupta |
| Designation |
Junior resident |
| Affiliation |
Dr. Rajender Prasad Govt. Medical College, Kangra |
| Address |
Department of Obstetrics and Gynecology, Dr. Rajender Prasad Govt. Medical College, Kangra
Suresh Saini Niwas , Sadarpur , Tanda Distt. Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418038485 |
| Fax |
|
| Email |
guptayamini99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Yamini Gupta |
| Designation |
Junior resident |
| Affiliation |
Dr. Rajender prasad govt. medical college, Kangra |
| Address |
Department of Obstetrics and Gynecology, Dr. Rajender Prasad Govt. Medical College, Kangra
Suresh Saini Niwas Sadarpur , Tanda Distt. Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418038485 |
| Fax |
|
| Email |
guptayamini99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Mamta Mahajan |
| Designation |
Associate professor |
| Affiliation |
Dr. Rajender prasad govt. medical collage kangra |
| Address |
Dr. Rajender Prasad Government Medical College , Kangra
Department of Obstetrics and genecology, Dr. Rajender prasad govt. medical college, Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8219953230 |
| Fax |
|
| Email |
drmamtamahajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rajender Prasad Movernment Medical College, Kangra at Tanda Distt. Kangra Pincode - 176001
Himachal Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Dr. Rajender Prasad government medical college , kangra |
| Address |
VPO Tanda Kangra Himachal Pradesh 176001 |
| Type of Sponsor |
Government medical college |
|
|
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 Yamini Gupta |
Dr. Rajender Prasad Government medical collage Tanda |
Antenatal Ward, Department of obstetrics and gynecology
Kangra
HIMACHAL PRADESH |
9418038485
guptayamini99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr rajender prasad government medical collage |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: letrozole and misoprostol |
30 women receive 10 mg letrozole on each day 1,2 and 3 which is subsequently followed by 400 mcg misoprostol per vaginally every 3 hours |
| Comparator Agent |
Group B: mifepristone and misoprostol |
30 women receive 200 mg mifepristone on day 1 followed by 400 mcg misoprostol per vaginally every 3 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. maternal age 18-40 years
2. singleton pregnancy
3. gestational age between 13 to 24 weeks based on last menstrual period ,clinical examination, ultrasonography |
|
| ExclusionCriteria |
| Details |
1. grand multipara
2. multiple pregnancy
3. anemia (hb less then 8gm per dl)
4. any history of allergy to letrozole, mifepristone or misoprostol
5. presence of fibroid uterus
6. presence of intrauterine device
7. history of coagulopathy or thromboembolism
8. any medical disorder like liver disease, asthma, porphyria , hypertension, heart disease |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. successful abortion (complete abortion) within 36 hours
2. abortion to induction interval from start of treatment to expulsion of fetus |
1. successful abortion (complete abortion) within 36 hours
2. abortion to induction interval from start of treatment to expulsion of fetus |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| failure rate |
3 hours post 5th dose of misoprostol |
| side effects |
during and post 48 hours of delivery |
| post abortion fall in Hb levels |
post 24 hours of abortion |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/05/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
In second trimester, women seek termination of pregnancy due to various social and medical factors including delayed decisions, lack of awareness, poverty, limited education and availability of abortion services. Common reasons for mid-trimester abortions include fetal anomalies, uterine defects, placental causes and medical disorders. Abortions account for 8 percent of maternal mortality ratio in India and nearly 10 women reportedly die due to unsafe abortions everyday in India. Several methods are used for mid-trimester abortions, with medical methods being the most popular due to their effectiveness and fewer complications. Letrozole, mifepristone and misoprostol are commonly used drugs for this purpose. Mechanical methods using hygroscopic dilators and foleys catheter are also employed. Surgical methods like dilatation and evacuation are also used but have higher risks associated. In many countries, mifepristone is not available and is expensive compared to letrozole. There is a need to find a cheaper and easily available alternative. Letrozole is easily available as it is registered for treatment of estrogen dependent advanced breast cancers and infertility. Further studies are needed to refine abortion techniques, aiming to decrease procedure duration and potential complications while ensuring higher efficacy and patient tolerance. |