Home » Trials » SLCTR/2015/024
A randomized controlled study on the effect of birth education on the mode of delivery and pain perception in labour
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SLCTR Registration Number
SLCTR/2015/024
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A randomized controlled study on the effect of birth education on the mode of delivery and pain perception in labour
Public Title of Trial
A study on the effect of birth education on selected outcomes of labour
Disease or Health Condition(s) Studied
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
ERC Peradeniya Ref: 2014/EC/88
What is the research question being addressed?
What is the effect of a structured birth education program on mode of delivery and pain perception among young primi parous females in a tertiary care centre in Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
The study will be carried out at the Teaching Hospital, Peradeniya.
Consenting participants (expectant females) meeting inclusion/exclusion criteria will be recruited and randomized into 2 arms.
Arm 1 (intervention arm) During the second trimester, the participants and their partners will participate in a newly designed birth education program, which includes a component on the process of labour. This will be conducted by trained doctors/ Public health Midwifes and nursing officers in Sinhala and Tamil languages. The program will be conducted in a single session. Standard care will be continued.
Arm 2 (control arm) The participants randomized to this arm will receive standard care alone.
The outcomes will be assessed by the investigators (doctors), who will not be involved in the delivery of the educational intervention. Allocation of registration numbers will ensure that the investigators are blinded at the point of outcome assessment..
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ Within 24 hours of delivery ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
182 (91 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-12-01
Anticipated end date
2016-06-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2015-04-24
Approval number
2014/EC/88
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
R.D. Wijesinghe
Registrar in Obstetrics and Gynaecology
Dr. R.D. Wijesinghe
Teaching Hospital
Peradeniya
Sri Lanka
Tel: 94772207800
Mob: 94772207899
wijesingherd@gmail.com
Primary study sponsor/organization
Teaching Hospital Peradeniya
Peradeniya
Sri Lanka
Tel:+94812388261
Fax: +940812388371
info@peradeniya-hospital.health.gov.lk
http://www.peradeniya-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
