| CTRI Number |
CTRI/2024/03/064272 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of tablet Mifepristone (200 mg) in induction of labour in term pregnancy in a tertiary care hospital at chengalpatu district. |
|
Scientific Title of Study
|
To determine the effect of tablet Mifepristone (200mg) in induction of labour at term in a tertiary care centre at chengalpattu district a prospective study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thiripurasundari |
| Designation |
Assistant professor |
| Affiliation |
Karpaga vinayaga institute of medical sciences and research centre |
| Address |
No186thirukazhukundram mainroad alapakkam chengalpatu
No186thirukazhukundram mainroad alapakkam chengalpatu
Kancheepuram
TAMIL NADU
603003
India |
| Phone |
9488237145 |
| Fax |
|
| Email |
thiripurasundariramesh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thiripurasundari |
| Designation |
Assistant professor |
| Affiliation |
Karpaga vinayaga institute of medical sciences and research centre |
| Address |
No186thirukazhukundram mainroad alapakkam chengalpatu
No186thirukazhukundram mainroad alapakkam chengalpatu
TAMIL NADU
603003
India |
| Phone |
9488237145 |
| Fax |
|
| Email |
thiripurasundariramesh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Thiripurasundari |
| Designation |
Assistant professor |
| Affiliation |
Karpaga vinayaga institute of medical sciences and research centre |
| Address |
No186thirukazhukundram mainroad alapakkam chengalpatu
No186thirukazhukundram mainroad alapakkam chengalpatu
TAMIL NADU
603003
India |
| Phone |
9488237145 |
| Fax |
|
| Email |
thiripurasundariramesh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Karpaga Vinayaga Institute Of Medical Sciences and Research Centre |
|
|
Primary Sponsor
|
| Name |
Thiripurasundari |
| Address |
No 186 Thirukazhukundram main road alapakkam chengalpatu |
| Type of Sponsor |
Other [Self funding ] |
|
|
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 |
| DrsThiripurasundari |
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre |
No 35, department of obstetrics and gynaecology karpaga Vinayaga Institute Of Medical Sciences and Research Centre chinna kolambakkam Madurantakam chengalpatu
Kancheepuram
TAMIL NADU |
9488237145
thiripurasundariramesh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Karpaga Vinayaga Institute Of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Term pregnant women admitted in labour ward for induction of labour |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tablet Mifepristone |
Soften the cervix and improves the modified bishops score .dosage is 200 mg tablet once orally. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Term pregnant women admitted in labour ward for induction of labour in karpaga vinayaga institute of medical sciences and research centre.without any risk factors |
|
| ExclusionCriteria |
| Details |
Pregnant women with risk factors like preterm labour, diabetes, hypertension, antepartum haemorrhage,CPD,fever,anyother infection, fetal distress,malpresentation,heart disease,liver disease and any other medical illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in modified bishops scoring.increase
in rate of normal vaginal delivery |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Normal vaginal delivery |
24 to 48 hours |
|
|
Target Sample Size
|
Total Sample Size="185"
Sample Size from India="185"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="6" |
|
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
|
Term pregnant women admitted in labour ward for induction of labour with out any other medical illness and risk factors are given tablet Mifepristone 200 mg tablet orally.modified bishops score assesed before giving the tablet and at 24 hours and 48 hours . |