Home » Trials » SLCTR/2018/039

Effect of Birth Ball usage on Labour Outcome and Perinatal Outcome


SLCTR Registration Number


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


Scientific Acronym


Public Acronym


Brief title

Effect of Birth Ball usage on Labour Outcome and Perinatal Outcome

Universal Trial Number


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


Study design


Randomized controlled trial


Masking not used







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




Target number/sample size

34 each arm

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment


Date of study completion

Recruitment status


Funding source

None (Investigator funded)

Regulatory approvals

Not applicable

State of Ethics Review Approval



Date of Approval


Approval number


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

Contact Person for Public Queries

Dr. U.D.P. Ratnasiri
Consultant Obstertrician and Gynaecologist
Castle street hospital for women, Colombo 8, Sri Lanka
Mob: 718070550

Primary study sponsor/organization

Castle street hospital for women, Colombo 8

Secondary study sponsor (If any)


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


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results