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

04 Dec 2018

The date of last modification

Jan 28, 2019



Application Summary


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


Trial Details


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

  1. Singleton pregnancy
  2. Gestational age between 24 and 30 weeks
  3. Primigravidae

Exclusion criteria

  1. Women with chronic or pregnancy induced illnesses
  2. Presence of any contraindication to vaginal delivery
  3. Antepartum haemorrhage


Primary outcome(s)

    1. Duration of labour
    2. Pain during labour
      -Pain during labour will be assessed by a visual pain scale after the delivery
    3. Percentage of foetal distress
    4. Percentage of assisted vaginal deliveries
    5. Percentage of deliveries with a live non-asphyxiated baby
    6. Percentage of intrauterine death
    7. Percentage of Special Care Baby Unit admissions
    8. Percentage of babies with a APGAR score of less than 7 at 5 minutes of birth
    [

    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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization



Castle street hospital for women, Colombo 8



Secondary study sponsor (If any)

None





Trial Completion details


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