Home » Trials » SLCTR/2014/006
Effectiveness and safety in keeping the intra uterine Foley catheter for 24 hours versus 48 hours for induction of labour: A randomized controlled trialion of labour: A Randomized controlled trail
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SLCTR Registration Number
SLCTR/2014/006
Date of Registration
The date of last modification
Apr 30, 2019
Trial Status
Scientific Title of Trial
Effectiveness and safety in keeping the intra uterine Foley catheter for 24 hours versus 48 hours for induction of labour: A randomized controlled trialion of labour: A Randomized controlled trail
Public Title of Trial
Effectiveness and safety in keeping the intra uterine Foley catheter for 24 hours versus 48 hours for preparing uterine cervix for induction of labour
Disease or Health Condition(s) Studied
Induction of labour
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC-13-184 ( Ethics Review Committee of the Faculty of Medicine, University of Colombo)
What is the research question being addressed?
What is the effectiveness and safety of a Foley catheter kept intra-uterine for 48 hours for induction of labour compared to keeping it for 24 hours?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Applicable
Intervention(s) planned
Participants will be allocated to two groups by block randomization.
Foley induction will be carried out after obtaining blood for C-reactive protein (CRP) level.
The intervention group will have the foley catheter inserted for 48 hours while the control group will have it inserted for 24 hours.
C-reactive protein level will be repeated 20 hours after removal of Foley catheter
Inclusion criteria
Exclusion criteria
Primary outcome(s)
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1.
|
[
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Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
93 per arm
Countries of recruitment
Sri Lanka
Anticipated start date
2014-04-01
Anticipated end date
2014-08-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2014-01-23
Approval number
EC-13-184
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
W.M.R.P.T.B Wickramasinghe
Registrar, Obstetrics and Gynaecology
Professorial unit, De Soysa Hospital for Women, Colombo 08
0112662621
0718255472
ruwan_parakrama@yahoo.com
Contact Person for Public Queries
Prof H.M. Senanayake
Head/Department of Obstetrics and Gynaecology Faculty of Medicine, Colombo
Professorial unit, De Soysa Hospital for Women, Colombo 08
0112695300 (ext161)
Gynobs_colombo@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
