Home » Trials » SLCTR/2011/002
Intra cervical Foley catheter versus oral misoprostol for pre induction cervical ripening of post dated pregnancies. A randomized controlled trial
-
SLCTR Registration Number
SLCTR/2011/002
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Intra cervical Foley catheter versus oral misoprostol for pre induction cervical ripening of post dated pregnancies. A randomized controlled trial
Public Title of Trial
Insertion of Foley catheter to uterine cervix versus oral misoprostol for preparation of uterine cervix for induction of labour in post dated pregnancies
Disease or Health Condition(s) Studied
Effects of Foley catheter versus oral misoprostol for pre-induction cervical ripening
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
In women with post dated pregnancies is oral misoprostol better than insertion of intra-cervical Foley catheter for pre-induction ripening of the cervix?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Women will be randomly allocated to two groups by using stratified (primi/multi) block randomization at 40 weeks and 6 days. One group will have the Foley catheter inserted and the other group will have two doses of oral misoprostol 25 micro grams 4 hours apart.
Inclusion criteria
Consecutive women with uncomplicated singleton pregnancies having a cephalic presentation at period of gestation of 40 weeks and 6 days
Exclusion criteria
Complicated pregnancies – both maternal or fetal complications. Pregnancies with uncertain dates not confirmed by early scan, even though clinically considered as 41 weeks. Multiple pregnancies. Pregnancies with contraindication for normal vaginal delivery. Pregnancies with previous caesarean section. Women who have had insertion of intra cervical Foley catheter or vaginal PGE2 before 40 + 6 days. Contraindication for the use of misoprostol.
Primary outcome(s)
|
1.
Proportions establishing labour by day two after the intervention |
[ Morning of day 2 ] |
|
2.
Proportions of women suitable for induction of labour with modified Bishop score (mBS) 6 or more by day two after the intervention |
[ Morning of day 2 ] |
|
3.
Induction to delivery interval |
[ Morning of day 2 ] |
Secondary outcome(s)
|
1.
Induction to delivery interval |
[ After delivery ] |
|
2.
Mode of delivery |
[ After delivery ] |
|
3.
Side effects of misoprostol therapy |
[ After delivery ] |
Target number/sample size
150
Countries of recruitment
Sri Lanka
Anticipated start date
2011-02-01
Anticipated end date
2012-01-10
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2010-11-24
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof. Malik Goonewardene
Senior Professor and Head of the Dept. of Obstetrics and Gynaecology
University of Ruhuna, Faculty of Medicine, Galle,
(091) 2246878, 2234801/3, 2234730 (091) 2222314, Int: (+94)
malikg@eureka.lk
Contact Person for Public Queries
Prof. Malik Goonewardene
Senior Professor and Head of the Dept. of Obstetrics and Gynaecology
University of Ruhuna, Faculty of Medicine, Galle,
(091) 2246878, 2234801/3, 2234730 (091) 2222314, Int: (+94)
malikg@eureka.lk
Primary study sponsor/organization
University of Ruhuna
Faculty of Medicine, P.O. Box 70, Galle
(091) 2246878, 2234801/3, 2234730 94 91 2222314
malikg@eureka.lk
www.medi.ruh.ac.lk
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
