| CTRI Number |
CTRI/2025/01/078952 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Letrozole in second trimester medical termination of pregnancy. |
|
Scientific Title of Study
|
The effect of mifepristone and misoprostol on termination of second trimester pregnancy with and without Letrozole: a placebo controlled randomized clinical 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 |
S Murali |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Dept of OBG, 2nd floor, WCH Block, JIPMER, D.Nagar, Pondicherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
08940760837 |
| Fax |
|
| Email |
muralidraiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S Murali |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Dept of OBG, 2nd floor, WCH Block, JIPMER, D.Nagar, Pondicherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
08940760837 |
| Fax |
|
| Email |
muralidraiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Murali |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Dept of OBG, 2nd floor, WCH Block, JIPMER, D.Nagar, Pondicherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
08940760837 |
| Fax |
|
| Email |
muralidraiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of postgraduate medical education and research
D nagar, Puducherry, India
605006 |
|
|
Primary Sponsor
|
| Name |
Dr Murali S |
| Address |
Department of OBG, JIPMER, D nagar, Puducherry,India 605006 |
| Type of Sponsor |
Other [PI] |
|
|
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 Murali S |
Jawaharlal institute of postgraduate medical education and research |
Dept of OBG, 2nd floor, WCH Block, JIPMER, D.Nagar, Pondicherry 605006
Pondicherry
PONDICHERRY |
8940760837
muralidraiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee interventional studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O048||(Induced) termination of pregnancywith other and unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo tablet |
placebo tablet resembling Letrozole tablet for 3 days |
| Intervention |
Tablet Letrozole |
10mg oral Letrozole for three days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
12 to 24 weeks MTP |
|
| ExclusionCriteria |
| Details |
Severe anemia, heart disease, bleeding disorders, Previous LSCS, liver or renal disorders, known allergy or contraindications to the study drugs (chronic systemic use of corticosteroids; chronic adrenal failure; current therapy with anticoagulants; or inherited porphyria) Low lying placenta, previous history of hysterotomy, Breast feeding, Intrauterine device in situ, multiple gestation and concurrent usage of any other ripening agent like cervical Foley’s catheter placement. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete expulsion (including fetus and placenta). |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare induction-abortion interval, hospital stay, misoprostol dosage, need for surgical evacuation, side effects and acceptability of the two regimen in women undergoing termination of second trimester pregnancy. |
24 h after misoprostol adminstration,
Time of discharge. |
|
|
Target Sample Size
|
Total Sample Size="290"
Sample Size from India="290"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/04/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Second Trimester Medical termination of pregnancy are mainly done using a combination of misoprostol and mifepristone tablets. Although this combination is satisfactory, several women fail to expel the products of conception and require long hospital stay and multiple misoprostol dosages. Letrozole has been approved by WHO for first trimester pregnancy and has the potential to further improve the success rate of available misoprostol/mifepristone combination. In this RCT , the women in intervention arm will receive tablet Letrozole for 3 days along with standard misoprostol/mifepristone regimen. Women in control group will receive a placebo tablet in place of Letrozole along with standard misoprostol/mifepristone regimen. The primary outcome is to compare complete uterine evacuation within 24h of starting Misoprostol tablets. |