Home » Trials » SLCTR/2014/025
Induction of multiparous women at term using different methods: Prostaglandin E2 (dinopristone) vaginal gel, intracervical foley catheter insertion and sweeping of membrane: An open-label, randomised controlled trial.
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SLCTR Registration Number
SLCTR/2014/025
Date of Registration
The date of last modification
Apr 30, 2019
Scientific Title of Trial
Induction of multiparous women at term using different methods: Prostaglandin E2 (dinopristone) vaginal gel, intracervical foley catheter insertion and sweeping of membrane: An open-label, randomised controlled trial.
Public Title of Trial
Comparison of different approaches to labour induction among multi parous women at term
Disease or Health Condition(s) Studied
Induction of labour
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
1111-1156-8163
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
What is the comparative effectiveness of 3 methods, Prostaglandin E2 (dinopristone) vaginal gel, intracervical foley catheter insertion and sweeping of membrane for induction of labour in multiparous women?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Available
Intervention(s) planned
Consenting participants meeting inclusion/exclusion criteria will be allocated to four arms using block randomization. All the induction methods will be carried out from 40+4 weeks of gestation onwards.
Arm 1 (prostaglandin group): Dinoprostone gel be 2mg will be inserted following initial cervical assessment. If the cervix is unfavourable after six hours a second dose of prostaglandin (2mg) will inserted. Fetal wellbeing will be monitored by CTG at three hours and five hours after insertion of prostaglandin.
Arm 2 (foley catheter group): The foley catheter balloon will inserted through the cervical canal and the catheter bulb dilated with 60 ml of normal saline done. Sufficient cervical dilatation will result in the catheter dropping out. The foley catheter will be kept for a maximum of 48 hours. Fetal well being will be monitored by CTG and daily Doppler assessment.
Arm 3 (membrane sweeping group): The sweeping of membrane will done once daily till 41 weeks. Fetal well being will be monitored by CTG at 3 hours after membrane sweeping and daily Doppler assessment.
Arm 4 (control group): Spontaneous onset of labour will be awaited with fetal monitoring done daily by 20 minutes CTG and daily Doppler assessment.
All the cervical assessments will be done by the first senior house officer (SHO) and introduction of the cervical ripening induction method done by the second senior house officer. Fetal wellbeing (assessment of CTG, Doppler) will be by the third senior house officer.
Patients may exit the trial on their preference and will be excluded on development of dribbling or any life threatening complication to the mother or baby. Such situations will be managed according to standard protocols and unit policy. Grossly unfavourable induction of labour at 48 hours after intervention will be managed according to standard protocols and unit policy.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
|
[ Up to 72 hours after induction of labour . ] |
Secondary outcome(s)
1.
|
[ Up to 72 hours after induction of labour ] |
Target number/sample size
(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3564932/)
Countries of recruitment
Sri Lanka
Anticipated start date
2014-10-15
Anticipated end date
2014-11-18
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2013-12-06
Approval number
N/A
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
Institutional Address: | Galaha Road, Kandy, Sri Lanka |
Telephone: | +94-812396361 |
Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr.P.D.M.Pathiraja
Registrar in Obstetrics and Gynaecology
New unit for Obstetrics and Gynaecology
Teaching Hospital ,Peradeniya
0812388261
0772532828
madushan_pathi@yahoo.com
Contact Person for Public Queries
Dr AGSK Ranaraja
Registrar in Obstetrics and Gynaecology
New unit for Obstetrics and Gynaecology
Teaching Hospital ,Peradeniya
0812388261
0777802949
sisira2@hotmail.com
Primary study sponsor/organization
New unit for Obstetrics and Gynaecology
Teaching Hospital ,Peradeniya,
Kandy,
Sri Lanka
Tel: +94 812 222261
Fax: +94 812 233343
info@kandy-hospital.health.gov.lk
http://www.kandy-hospital.health.gov.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