| CTRI Number |
CTRI/2024/12/078099 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare Mifepristone and vaginal misoprosotol combination with vaginal misoprostol alone in the management of missed abortion in first trimester. |
|
Scientific Title of Study
|
A comparative study of Mifepristone and Vaginal misoprostol Versus Vaginal misoprostol alone in the management of First trimester Missed miscarriage |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sai Raja Nandini Kilari |
| Designation |
First year Post graduate, Department of Obstetrics and gynaecology |
| Affiliation |
Dr MGR educational and research institute deemed to be university |
| Address |
Department of Obstetrics and gynaecology, ACS medical college and hospital, poonamalle high road, Velappanchavadi, Chennai-600077
Maduravoyal, Chennai-600095, tamilnadu
Chennai
TAMIL NADU
600077
India |
| Phone |
8897276747 |
| Fax |
|
| Email |
nandinipandu3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G.Ganitha |
| Designation |
Professor, Department of Obstetrics and gynaecology |
| Affiliation |
Dr MGR educational and research institute Deemed to be university |
| Address |
Department of obstetrics and gynaecology, ACS medical college and hospital, poonamalle high road, velappanchavadi, Chennai-600077
Maduravoyal, Chennai-600095
Chennai
TAMIL NADU
600077
India |
| Phone |
9442032623 |
| Fax |
|
| Email |
drgganitha77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sai Raja Nandini Kilari |
| Designation |
First year postgraduate Obstetrics and gynaecology |
| Affiliation |
Dr MGR educational and research institute Deemed to be university |
| Address |
Department of obstetrics and gynaecology, ACS medical college and hospital, poonamalle high road, velappanchavadi, Chennai-600077
Maduravoyal, Chennai- 600095
Chennai
TAMIL NADU
600077
India |
| Phone |
8897276747 |
| Fax |
|
| Email |
nandinipandu3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and gynaecology, ACS medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Sai Raja Nandini Kilari |
| Address |
Flat 506 pooja diamond Anandham apartment ,poonamalle high road, Chennai- 600056 |
| 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 |
| DrSai raja nandini kilari |
ACS medical college and hospital |
Antenatal ward and Labour ward,Department of Obstetrics and gynaecology
Chennai
TAMIL NADU |
8897276747
nandinipandu3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O021||Missed abortion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mifepristone, Misoprostol |
Mifepristone
200 mg OD PO for 1 day
Misoprostol
400 mcg BD Per vaginal for 1 day |
| Intervention |
Misoprostol alone |
Misoprostol 400mcg BD per vaginal for 1 day alone |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women with scan finding of missed miscarriage the criteria include any one of these:
Intrauterine gestation with gestational sac - 20 mm with no evidence of an embryo/yolk sac.
Intrauterine gestation with CRL-6 mm without cardiac activity.
Intrauterine gestation with gestational sac -20 mm/CRL -6 mm with no growth in 7 days.
Radiological signs of abnormal pregnancy—irregular sac/debris within the gestational sac.
Conscious and co-operative patients.
Patients willing to give consent.
|
|
| ExclusionCriteria |
| Details |
Women who opted for alternative methods of miscarriage management (expectant or surgical).
Women with Missed miscarriages in second trimester.
Induced abortions.
Diagnosis of Incomplete miscarriage.
Hemodynamic instability.
Life threatening bleeding.
Contraindications to Mifepristone or Misoprostol.
Patients not willing to give consent.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate whether treatment with mifepristone plus vaginal misoprostol would result in a higher rate of successful medical management of missed miscarriage compared with vaginal misoprostol alone. |
1 assessment after 24 hours
2 assessment after 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy and safety of combination of Mifepristone and misoprostol Vs efficacy and safety of misoprostol alone.
|
1 assessment after 24 hours
2 assessment after 48 hours |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
13/01/2025 |
| 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="6"
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
|
This study is a randomized, double blind, parallel group trial comparing the efficacy of mifepristone 200mg OD PO for 1 day and misoprostol 400mcg BD Per vaginal for 1 day in 31 patients Vs misoprostol 800mcg BD Per vaginal alone for 1 day in other 31 patients. The primary outcome will be to investigate whether treatment with mifepristone plus vaginal misoprostol would result in a higher rate of successful medical management of missed miscarriage compared with vaginal misoprostol alone. The secondary outcome will be to assess the efficacy and safety of combination of Mifepristone and misoprostol Vs efficacy and safety of misoprostol alone.
|