| CTRI Number |
CTRI/2024/12/078374 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Simultaneous versus sequential use of Foley’s catheter and oxytocin for starting labour |
|
Scientific Title of Study
|
Simultaneous or sequential use of Foley’s catheter and oxytocin for induction of labour -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 |
Dr Swati sharma |
| Designation |
Junior resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of obstetrics and gynaecology , 3rd floor , nehru hospital, Postgraduate institute of medical education and research, sector 12,Chandigarh (160012)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7018488919 |
| Fax |
|
| Email |
jaipeyy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Bagga |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education & research, Chandigarh |
| Address |
Department of obstetrics and gynaecology,3rd floor, Nehru hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872494602 |
| Fax |
|
| Email |
rashmibagga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Bagga |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education & research, Chandigarh |
| Address |
Department of obstetrics and gynaecology,3rd floor, Nehru hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872494602 |
| Fax |
|
| Email |
rashmibagga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute Of Medical Education And Research sector 12 Chandigarh (160012) |
|
|
Primary Sponsor
|
| Name |
Dr Swati sharma |
| Address |
Postgraduate Institute Of Medical And Research sector 12 Chandigarh (160012) |
| 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 Swati Sharma |
Postgraduate institute of medical education & research |
Clean labor room , 3rd floor D block , Department of obstetrics and gynaecology,3rd floor, Nehru hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
7018488919
jaipeyy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural) Post Graduate Institute of Medical Education and Research , Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
pregnancy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Foleys intrauterine catheter |
Foleys intrauterine catheter is a mechanical method used for cervical ripening and induction of labor. |
| Intervention |
Oxytocin |
Oxytocin is a hormone that induces and augments labor. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Gestational age greater than 34 weeks
2.Bishops score six or less
3.Single live fetus with cephalic presentation
4.Intact membranes
5.Reactive non stress test (NST) |
|
| ExclusionCriteria |
| Details |
1.Previous uterine scar (caesarean section or myomectomy)
2.Parity greater than 3
3.Fetal congenital malformations
4.Severe fetal growth restriction(estimated fetal weight less than 3rd centile and/or abnormal Doppler changes in umbilical artery )
5.Pre-eclampsia with severe features /eclampsia
6.Antepartum haemorrhage
7.Premature rupture of membranes (PROM)
8.Cervicovaginal infections
9.Medical disorders (heart disease, seizure disorder, severe anaemia, renal disease,
uncontrolled diabetes, uncontrolled hypertension, retropositive status)
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine induction to delivery interval and compare it in both groups |
11 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Caesarean section (CS) rate 2. Incidence of uterine contraction abnormalities 3. Infectious morbidity in the mother (chorioamnionitis or puerperal sepsis) 4. Composite Neonatal outcome |
11 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2 |
|
Date of First Enrollment (India)
|
29/12/2024 |
| 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="0"
Months="11"
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
|
we aim to determine
whether simultaneous use of Foley’s and oxytocin will be advantageous to achieve vaginal delivery after IOL without an increase in the oxytocin to delivery interval or the CS rate as
compared to sequential use. If found beneficial, it will reduce overnight hospital stay for
cervical ripening with Foley’s kept for 12 hours. |