| CTRI Number |
CTRI/2025/12/098372 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Standard-Dose and High Dose Mifepristone Regimens for Induction of Labour After Intrauterine Fetal Demise |
|
Scientific Title of Study
|
Comparison of standard and high dose mifepristone regimen for labour induction after foetal demise |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanchita Jha |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate institute of medical education and research |
| Address |
Department of Obstetrics and Gynaecology,PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9059171887 |
| Fax |
|
| Email |
sanchitajha15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanchita Jha |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate institute of medical education and research |
| Address |
Department of obstetrics and gynaecolgy, PGIMER, Sector-12 ,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9059171887 |
| Fax |
|
| Email |
sanchitajha15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanchita Jha |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate institute of medical education and research |
| Address |
Department of Obstetrics and gynaecolgy,PGIMER, Sector-12 ,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9059171887 |
| Fax |
|
| Email |
sanchitajha15@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Department of Obstetrics and Gynaecolgy, PGIMER, Sector-12 |
| 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 Sanchita Jha |
Post Graduate Institute of Medical Education and Resarch |
Department of Obstetrics and Gynaecolgy, PGIMER, Sector-12 ,Chandigarh
Chandigarh
CHANDIGARH |
9059171887
sanchitajha15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate institute of medical efucation and research ,chandigarh Institutional ethics committe(Intramural) |
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 |
High dose of mifepristone compared to standard dose |
Standard dose of 200 mg one dose is used as compared to 200 mg for 4 doses as in our study |
| Intervention |
Mifepristone in dose 200 mg 12 hourly for 48 hours |
Higher doses of mifepristone that is 200 mg 12 hourly for 48 hours as compared to standard dose whic is single 200 mg dose will be used |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy
Confirmed IUFD of 28 weeks or more
Longitudinal lie |
|
| ExclusionCriteria |
| Details |
Patient in whom mifepristone is contraindicated
Unknown scar
Previous 2 or more LSCS
Low lying placenta
History of myomectomy
Medical surgical disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Induction delivery interval |
Baseline,48 hours,72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of successful vaginal delivery |
48 hours |
| Reduction in requirement & total dosage of misoprostol used |
72 hours |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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="1"
Months="2"
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
|
This pilot randomized controlled trial aims to evaluate whether a high-dose mifepristone regimen is more effective than the standard dose for induction of labor in cases of intrauterine fetal demise. The study assesses the impact of increasing mifepristone dose on reducing the induction to delivery interval, lowering the total misoprostol requirement, and improving the rate of successful vaginal delivery. The trial also examines whether high-dose mifepristone can minimize misoprostol-related adverse effects, thereby enhancing the overall safety and effectiveness of the induction process.
|