Home » Trials » SLCTR/2018/039
Effect of Birth Ball usage on Labour Outcome and Perinatal Outcome
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SLCTR Registration Number
SLCTR/2018/039
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effect of Birth Ball usage on Labour Outcome and Perinatal Outcome
Public Title of Trial
Effect of birth ball usage on labour duration and pain and perinatal outcomes
Disease or Health Condition(s) Studied
Labour
Scientific Acronym
None
Public Acronym
None
Brief title
Effect of Birth Ball usage on Labour Outcome and Perinatal Outcome
Universal Trial Number
U1111-1220-0209
Any other number(s) assigned to the trial and issuing authority
Ethics Review Committee of Faculty of Medicine-Colombo EC-18-001
What is the research question being addressed?
Does birth ball exercises reduce labour pain and duration and improve perinatal outcome ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Uncontrolled
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2-3
Intervention(s) planned
The study will be conducted at ward 10, Castle street hospital for women, Colombo 8.
Selection of the study participants for the research will be done at the antenatal clinic.
A printed information sheet and a video clip demonstrating the birth ball exercise will be used to explain the procedure.
The study participants will be divided into the intervention group and the control group by using the sequentially numbered sealed opaque envelopes.
A training programme to introduce the birth ball exercise will be conducted for the study participants who are selected to the intervention group.
Birth ball exercise will be conducted in each clinic visit.
Duration of exercise in a clinic visit will be 15 minutes.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ 24 hours after delivery ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
34 each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2018-12-10
Anticipated end date
2019-09-30
Date of first enrollment
2018-12-06
Date of study completion
Recruitment status
Recruiting
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-07-19
Approval number
EC-18-001
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
Dr. B.S.C. Jothirathne
Registrar in Gynecology and Obstertrics
Castle Street Hospital for Women Borella, Colombo 08, Sri Lanka
Tel: 0112695529
Mob: 0773367411
Fax: 0112695244
sampathchanuthidulanma@gmail.com
Contact Person for Public Queries
Dr. U.D.P. Ratnasiri
Consultant Obstertrician and Gynaecologist
Castle street hospital for women, Colombo 8, Sri Lanka
0112695529
Mob: 718070550
0112695244
udpratnasiri@yahoo.com
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
