Home » Trials » SLCTR/2018/039


Effect of Birth Ball usage on Labour Outcome and Perinatal Outcome -

SLCTR Registration Number

SLCTR/2018/039


Date of Registration

04 Dec 2018

The date of last modification

Dec 04, 2018



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 of 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


Purpose

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

Primary outcome(s) - Time of assessment(s)

24 hours after delivery


Secondary outcome

None


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Pending


State of ethics review approval

Approved by Ethics Review Committee, Faculty of Medicine, University of Colombo on 19th July 2018 (Ref. No:EC-18-001)


Funding source

None (Investigator funded)



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