| CTRI Number |
CTRI/2024/02/062460 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of oral Mifepristone as a cervical ripening agent to induce labour in low-risk full-term live pregnancy beyond 40 weeks of gestation. |
|
Scientific Title of Study
|
Study of oral Mifepristone as a cervical ripening agent to induce labour in low-risk full-term live pregnancy beyond 40 weeks of gestation - a randomized controlled 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 |
Dr Nikita Yadav |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. S.N. Medical College, Jodhpur |
| Address |
Dept of OBGYN, Labour Room, Umaid Hospital, Jodhpur, Rajasthan
Dept of OBGYN, Labour Room, Umaid Hospital, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
331305
India |
| Phone |
09671457133 |
| Fax |
|
| Email |
nikitayadav97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Hanslata Gehlot |
| Designation |
Senior Professor & Unit Head |
| Affiliation |
Umaid Hospital, Dr. S.N. Medical College, Jodhpur |
| Address |
Unit-3, Dept of OBGYN, Umaid Hospital, Jodhpur, Rajasthan
Unit-3, Dept of OBGYN, Umaid Hospital, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
331305
India |
| Phone |
09414135070 |
| Fax |
|
| Email |
pummyia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Hanslata Gehlot |
| Designation |
Senior Professor & Unit Head |
| Affiliation |
Umaid Hospital, Dr. S.N. Medical College, Jodhpur |
| Address |
Unit-3, Dept of OBGYN, Umaid Hospital, Jodhpur, Rajasthan
Unit-3, Dept of OBGYN, Umaid Hospital, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
331305
India |
| Phone |
09414135070 |
| Fax |
|
| Email |
pummyia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Umaid Hospital- Government Medical College |
|
|
Primary Sponsor
|
| Name |
Umaid Hospital, Dr SN Medical College |
| Address |
Umaid Hospital, Jodhpur |
| 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 Nikita Yadav |
Umaid Hospital |
Department of OBGYN, Labour room, Umaid Hospital, Dr. S.N. Medical College, Jodhpur
Jodhpur
RAJASTHAN |
9671457133
nikitayadav97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr. Sampurnanand Medical College, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Expectant Management |
In the comparator arm, we will not intervene, and will do expectant management between 40-41 weeks. |
| Intervention |
Tab Mifepristone |
We will give Tab Mifepristone 200mg orally 2 doses 24 hours apart and wait till 72 hours from the first dose for Bishop score to improve |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant females of age between 18-45 years old, Primigravida or Gravida 2, with singleton live pregnancy with cephalic presentation of gestational age 40-41 weeks without any obstetric complications, having an unripe cervix and intact membranes.
|
|
| ExclusionCriteria |
| Details |
Pregnant females having any obstetric complications, any previous uterine surgery, any fetal compromise. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gain in Bishops score
|
Baseline, at 24 hours, 48 hours, 72 hours from first dose of Mifepristone
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Duration of induction to active phase of labour & induction to delivery interval.
2)Mode of delivery
3)Maternal & perinatal complications
|
1) When women enters active stage of labour & when she delivers
2) At delivery
3) At delivery
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
08/02/2024 |
| 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="0"
Months="3"
Days="30" |
|
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
|
Through this study we want to see the effect of indirect labour inducing agent- Mifepristone on cervical ripening in an unripe cervix at term in low-risk pregnant female population. So, in one arm we will give Tab Mifepristone for induction and in the control arm expectant management will be done. |