| CTRI Number |
CTRI/2018/10/016154 [Registered on: 25/10/2018] Trial Registered Prospectively |
| Last Modified On: |
25/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Foleys catheter for induction of labour] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial comparing the use of foleys catheter with and without weights on induction of labour |
|
Scientific Title of Study
|
A randomized controlled trial comparing a 30-ml Foley catheter balloon without weight and a 30-ml Foley catheter balloon with 500gm weight [500ml of 5% DEXTROSE ] for preinduction cervical ripening for women with past dates requiring Induction of labour. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anne George Cherian |
| Designation |
Associate Professor (OG) |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Department of Community Health,
Christian Medical College,
Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9487760904 |
| Fax |
|
| Email |
annegc97@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Anne George Cherian |
| Designation |
Associate Professor (OG) |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Department of Community Health,
Christian Medical College,
Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9487760904 |
| Fax |
|
| Email |
annegc97@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Anne George Cherian |
| Designation |
Associate Professor (OG) |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Department of Community Health,
Christian Medical College,
Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9487760904 |
| Fax |
|
| Email |
annegc97@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Christian Medical College,
Vellore, Tamil Nadu 632 002 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Vellore |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anne George Cherian |
Christian Medical College and Hospital |
Dept of obstetrics and Gynecology,
CMC, Vellore
Vellore
TAMIL NADU |
9487760904
annegc97@yahoo.co.in |
| Anne George Cherian |
Christian Medical College and Hospital |
Department of Community Health
Vellore
TAMIL NADU |
9487760904
annegc97@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O60-O77||Complications of labor and delivery, (2) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Foleys bulb with 30 ml saline |
Induction of labour will be done using a foleys bulb with 30 ml saline. |
| Intervention |
Foleys bulb with 30 ml saline with 500 gm weight attached to it |
Induction of labour will be done using a foleys bulb with 30 ml saline and a 500 gm weight will be attached to it. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Singleton pregnany
2.Primigravida and multigravida needing induction at 39 weeks and beyond
3.Cephalic presentation
4.Bishops score less than or equal to 4 |
|
| ExclusionCriteria |
| Details |
1.Previous LSCS
2.Previous endometritis
3.Any high risk factors requiring induction at <39 weeks
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Prevention of LSCS for failed induction |
Time from induction to vaginal delivery or Caesarean delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Effectiveness
2. Complications
3. Satisfaction |
Time to foley expulsion
Time to active phase of labour |
|
Target Sample Size
Modification(s)
|
Total Sample Size="398"
Sample Size from India="398"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="399" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2018 |
| Date of Study Completion (India) |
31/07/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
25. Induction of labor using Foley catheter with weight attached versus without weight attached: A randomized control trial. Anne George Cherian, Tobey Ann Marcus, Tunny Sebastian, Swathi Rathore, Jiji Elizabeth Mathews.
First published: 30 April 2021
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a prospective randomized controlled trial which will be done in pregnant women at term with no risk factors. Women in the arm randomized to induction with a foleys catheter will be induced with the foleys catheter inflated with 30 ml sterile water. The other group will be induced with foleys catheter inflated with 30 ml sterile water. The end of this foleys catheter will be attached to a 500 gm weight (500ml of 5% dextrose). These women will then be induced with oxytocin after 12 hours of inserting the foleys catheter if they do not have uterine contractions. After informed consent, women will be recruited from labour room and randomized to either of the groups. Data regarding duration of labour, fever, CTG abnormalities, neonatal morbidity etc., will be collected. The data will be analyzed to compare safety and efficacy in both groups. |