Home » Trials » SLCTR/2016/024
Oral misoprostol for 48 hours versus an intracervical Foley catheter for 48 hours for induction of labour in post dated pregnancies : a randomized control trial
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SLCTR Registration Number
SLCTR/2016/024
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Oral misoprostol for 48 hours versus an intracervical Foley catheter for 48 hours for induction of labour in post dated pregnancies : a randomized control trial
Public Title of Trial
Oral misoprostol compared to intracervical Foley catheter 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
30.08.2016:3.10 (ERC: Ruhuna)
What is the research question being addressed?
Are three doses of oral Misoprostol 50 micrograms given four hours apart per day for 48 hours (maximum 6 doses) more effective than the insertion of an intracervical Foley catheter for 48 hours, for induction of labour in post dated pregnancies?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
Study setting: Antenatal ward of Academic Obstetric Unit, Teaching Hospital, Mahamodera Galle.
Stratified (primiparous / multiparous) block randomisation, using computer generated random numbers and sequential allocation using sealed opaque envelopes will be used to allocate participants into the two arms of the trial.
Arm 1 will be administered three doses of oral Misoprostol 50 micrograms, given four hours apart per day for 48 hours (maximum 6 doses).
Arm 2 will have insertion of an intracervical Foley catheter for 48 hours.
Single blinding will be ensured as the investigator assessing the outcomes will be blinded to the interventional status.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ After 48 hours of the intervention ] |
Secondary outcome(s)
|
1.
|
[ At the time of discharge of the mother and the baby from the hospital ] |
Target number/sample size
144 (72 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2016-10-17
Anticipated end date
2017-04-30
Date of first enrollment
2016-10-13
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2016-10-04
Approval number
30.08.2016:3.10
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
Professor Malik Goonewardene
Senior Professor & Chair
Department of Obstetrics and Gynecology,
Faculty of Medicine,
University of Ruhuna,
PO Box 70,
Galle, Sri Lanka.
Tel: +94 91 2246878
Mob: +94 0777 921051
Fax: +94 91 2222314
malikg@eureka.lk
Contact Person for Public Queries
Dr. J.P.B.Asela Amarasena
Registrar
Teaching Hospital,
Mahamodara, Galle,
Sri Lanka
Tel: +94 91 2246878
Mob: +94 071 6156893
amarasenaasela@gmail.com
Primary study sponsor/organization
Department of Obstetrics and Gynecology Faculty of Medicine, University of Ruhuna
PO Box 70,
Galle, Sri Lanka.
Tel: +94 91 2246878
Fax: +94 91 2222314
malikg@eureka.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
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
