| CTRI Number |
CTRI/2024/11/077171 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Foleys catheter induction] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Transcervical Foleys catheter placement, for 6 hours versus 12 hours ,for
induction of labor.
-A RANDOMISED CONTROL TRIAL |
|
Scientific Title of Study
|
EFFICACY OF TRANSCERVICAL FOLEYS CATHETER PLACEMENT,FOR 6 HOURS VERSUS 12 HOURS,FOR INDUCTION OF LABOR -A RANDOMISED 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 |
AnushreeCM |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,LOK NAYAK HOSPITAL,MAULANA AZAD MEDICAL COLLEGE
BAHADUR SHAH ZAFAR MARG,
NEAR DELHI GATE
Room no 129 ,LNRDH ladies hostel
,opposite to special ward ,MAMC NEW DELHI
New Delhi
DELHI
110002
India |
| Phone |
8296394904 |
| Fax |
|
| Email |
anushreecm1809@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAKUN TYAGI |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Obstetrics and Gynaecology
Maulana Azad Medical College and Associated Hospital, New Delhi-110002
Department of Obstetrics and Gynaecology
Maulana Azad Medical College and Associated Hospital, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
8860188763 |
| Fax |
|
| Email |
tyagishakun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHAKUN TYAGI |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Obstetrics and Gynaecology
Maulana Azad Medical College and Associated Hospital, New Delhi-110002
Department of Obstetrics and Gynaecology
Maulana Azad Medical College and Associated Hospital, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
8860188763 |
| Fax |
|
| Email |
tyagishakun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology
Maulana Azad Medical College and Associated Hospital, New Delhi-110002
|
|
|
Primary Sponsor
|
| Name |
ANUSHREE C M |
| Address |
Department of Obstetrics and Gynaecology
Maulana Azad Medical College and Associated Hospital, New Delhi-110002
|
| 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 |
| DR SHAKUN TYAGI |
MAULANA AZAD MEDICAL COLLEGE |
Department of Obstetrics and Gynaecology
Maulana Azad Medical College and Associated Hospital, New Delhi-110002
New Delhi
DELHI |
8860188763
tyagishakun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMC INSTITUITIONAL ETHICS COMMITTEE |
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 |
| Intervention |
induction of labor using transcervical foleys catheter |
to compare efficacy of transcervical foleys catheter placement for 6hrs versus 12 hrs for induction of labor |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
women admitted in labor ward for induction of labor |
|
| ExclusionCriteria |
| Details |
previous caeserean delivery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| difference in induction to delivery interval in 6 hours and 12 hours foleys catheter placement groups |
6 hours versus 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| various maternal and neonatal outcomes like change in bishops score after intervention ,time to delivery after foleys catheter removal ,mode of delivery and neonatal outcomes like APGAR score ,birth weight ,neonatal sepsis ,NICU admission |
6 hours versus 12 hours |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
23/12/2024 |
| 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="1"
Months="0"
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
|
TITLE OF THESIS : Efficacy of transcervical foleys catheter placement ,for 6 hours versus 12 hours ,for induction of labor -A Randomised control trail. AIM -to compare induction to delivery interval, in 6 hours versus 12 hours transcervical foleys catheter placement group , for induction of labor . STUDY PERIOD -1 year PRIMARY OUTCOME : Difference in induction to delivery interval in 6 hours and 12 hours foleys catheter placement groups SECONDARY OUTCOME :to study various maternal and perinatal outcomes in 6 hours and 12 hours foleys catheter placement groups |