| CTRI Number |
CTRI/2026/03/105237 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
08/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial of mifepristone alone versus mifepristone -misoprostol combination regimen for induction of labor in late intrauterine fetal death. |
|
Scientific Title of Study
|
Randomized control study of mifepristone alone versus mifepristone -misoprostol combination regimen for induction of labor in late intrauterine fetal death. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reena Rani Punia |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Obstetrics & Gynaecology Maulana Azad Medical College Bahadur shah zafar marg New Delhi
Central
DELHI
110002
India |
| Phone |
09958770203 |
| Fax |
|
| Email |
dr.reena0310@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Yadav |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Obstetrics & Gynaecology Maulana Azad Medical College Bahadur shah zafar marg New Delhi
Central
DELHI
110002
India |
| Phone |
8447605286 |
| Fax |
|
| Email |
komalmamc2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Yadav |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Obstetrics & Gynaecology Maulana Azad Medical College Bahadur shah zafar marg New Delhi
Central
DELHI
110002
India |
| Phone |
8447605286 |
| Fax |
|
| Email |
komalmamc2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical college and Lok Nayak Hospital, Bahadur shah Zafar marg, New Delhi- 110002, India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College and Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi- 110002, India |
| 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 Komal Yadav |
Maulana Azad medical college |
Department of obstetrics and gynaecology, Maulana Azad medical college, Bahadur shah Zafar marg, New Delhi- 110002
New Delhi
DELHI |
8447605286
komalmamc2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O364||Maternal care for intrauterine death, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Induction of labor in late intrauterine fetal death. |
Induction of labor with FIGO regime (Tablet Mifepristone 200 milligrams per orally single dose, after 24- 48 hours Tablet Misoprostol 50-100 micrograms every 2 hours per orally or Tablet Misoprostol 25 -50 micrograms every 4 hours per vaginally) in late intrauterine fetal death when period of gestation is more than 28 weeks. |
| Intervention |
Induction of labor in late intrauterine fetal death. |
Induction of labor with Tablet Mifepristone 200 milligrams per orally thrice daily for two days in late intrauterine fetal death when period of gestation is more than 28 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy with late intrauterine fetal death and non-scarred uterus.
|
|
| ExclusionCriteria |
| Details |
1.Deranged liver function tests/ kidney function tests/ coagulation profile.
2.Known allergy or contraindication for Mifepristone or Misoprostol.
3.Known case of inherited porphyria.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of women who deliver vaginally with Mifepristone alone vs Mifepristone- Misoprostol
combination regimen within 5 days of initiation of regimen.
|
Proportion of women who deliver vaginally with Mifepristone alone vs Mifepristone- Misoprostol
combination regimen within 5 days of initiation of regimen.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mean induction to delivery time in both regimens
2.Proportion of women requiring additional intervention (medical/ surgical).
|
Women who deliver vaginally within 5 days of initiation of regimen. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
10/03/2026 |
| 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 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
|
AIM- To study the efficacy of Mifepristone alone vs Mifepristone-
Misoprostol combination regimen for induction of labor in cases of late
intrauterine fetal death. Primary Outcome: Proportion of women who
deliver vaginally with Mifepristone alone vs Mifepristone- Misoprostol
combination regimen within 5 days
of initiation of regimen. Secondary Outcomes: 1.
Mean induction to delivery time in
both regimens 2.
Proportion of women requiring
additional intervention (medical/ surgical).
|