Condition category
Pregnancy and Childbirth
Date applied
19/04/2018
Date assigned
10/05/2018
Last edited
10/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Hospital admission in the latent phase of labour (or ‘early labour’) is associated with higher rates of intervention, such as using a hormone drip to speed up labour, breaking waters, continuous electronic foetal monitoring and Caesarean section. These all contribute to increased problems for mothers and babies during and after birth. Women sent home from hospital in early labour to ‘await events’ feel anxious and say that pain is their main reason for seeking hospital admission in early labour.
Using a birth ball to remain mobile in full labour reduces women's pain perception and their anxiety. However, no research has examined the effect of using birth balls at home in early labour to see if women find their contractions less painful and have less complicated labours. Promoting birth ball use at home in the latent phase of labour may enhance women’s confidence and reduce their pain perception. This may help them to delay going into hospital until their labour is established.
This study involves a randomised, controlled, single centre trial with two parallel groups of low risk pregnant women.


Who can participate?
Pregnant women aged over 18 years who plan to give birth in hospital and have a low risk of problems giving birth.

What does the study involve?
Following recruitment and consent at 28 weeks’ gestation 332 women will be randomly allocated to two groups. The Intervention Arm will be asked to access an online animated 90-second infomercial and offered the loan of a birth ball to use early labour at home. Control Arm participants will receive normal care provided by the NHS Trust. Participants will be asked to record their pain on a scale from 0-10 when they go into hospital in labour. Both Arms will be followed up 6 weeks’ postnatally with an online questionnaire to evaluate how many women used the ball at home in early labour and whether they found it helpful.

What are the possible benefits and risks of participating?
There are no risks to the health of the mother or baby. For example, if the birth plan changes and it is recommended that labour should be induced or that the baby should be born by caesarean section, then participants are free to follow advice. Participants are not required to use the birth ball if they do not wish to do so, or stay on it for a fixed length of time. There are no immediate benefits for people taking part. in this part of the project. It is hoped that the information from this project will show whether the infomercial is acceptable to families and whether using the birth ball in early labour helps women to have more normal births.

Where is the study run from?
St. Mary's Hospital, Newport, Isle of Wight, UK.

When is the study starting and how long is it expected to run for?
Participants will be recruited between February 2018 and October 2018.

Who is funding the study?
Wessex Integrated Clinical Academic Training Programme through Bournemouth University and the Isle of Wight NHS Trust.

Who is the main contact?
Dominique Mylod, dmylod@bournemouth.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Dominique Mylod

ORCID ID

http://orcid.org/0000-0003-4683-6228

Contact details

Faculty of Health and Social Sciences
Doctoral College
702 Royal London House
Christchurch Road
Bournemouth
BH1 3LT
United Kingdom
07799883514
dmylod@bournemouth.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 4.1

Study information

Scientific title

Using a birth ball to reduce pain perception in the latent phase of labour: a randomised controlled trial

Acronym

The BALL trial

Study hypothesis

Using a birth ball at home in the latent phase of labour reduces pain perception compared to usual care.

Ethics approval

South Central- Hampshire B Research Ethics Committee, 11/12/17, 17/SC/0534

Study design

Single-centre non-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format; please use contact details to request a Participant Information Sheet.

Condition

Pain in the latent phase of labour

Intervention

Following recruitment and consent at 28 weeks’ gestation, participants are randomised into Control or Intervention Arms via an online randomisation service (Sealed Envelope 2016). The Control Arm receives usual care. The Intervention Arm accesses a 90-second online animated infomercial 'Having A Ball in Early Labour' at 36 weeks' gestation. They are also offered the loan of a birth ball to use at home in the latent phase of labour. Participants will be asked to record their pain on a scale from 0-10 when they go into hospital in labour. Both Arms will be followed up 6 weeks postnatally with an online questionnaire to evaluate how many women used the ball at home in early labour and whether they found it helpful.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Proportion of participants who show a reduction in visual analogue scale (VAS) pain scores of 1 point or more when women are admitted to hospital in labour.

Secondary outcome measures

1. Changes in Outcome Expectancy and Self-Efficacy Expectancy CBSEI scores in Intervention Arm participants before and after viewing the infomercial
2. Amniotomy, syntocinon augmentation, CEFM, epidural and CS rates will be descriptively analysed as the sample size is too small to detect significant differences
3. Measures of birth ball uptake, acceptability and satisfaction will be descriptively presented

Overall trial start date

05/01/2015

Overall trial end date

01/02/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Able to understand, read and speak English
3. Planned hospital labour and vaginal birth
4. Spontaneous labour
5. Singleton cephalic pregnancy >37 weeks gestation
6. Home internet access

Participant type

Other

Age group

Adult

Gender

Female

Target number of participants

332

Participant exclusion criteria

1. <18 years old
2. Not able to understand, read and speak English
3. Planned home birth
4. Elective Caesarean section (CS)
5. Induction of labour
6. Non-cephalic presentation
7. <37 weeks gestation
8. Body Mass Index >35 kg/m2 at booking
9. Previous CS or other uterine surgery
10. Antenatal diagnosis of foetal anomaly, intrauterine growth restriction, foetal growth <10th centile or intrauterine death
11. Pre-existing maternal medical conditions e.g. cardiac, endocrine
12. Previous stillbirth
13. Obstetric complications e.g. intrahepatic cholestasis
14. Current use of recreational or prescribed analgesic medication

Recruitment start date

01/02/2018

Recruitment end date

31/10/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St. Mary's Hospital
Parkhurst Road
Newport, Isle of Wight
PO30 5TG
United Kingdom

Sponsor information

Organisation

Bournemouth University

Sponsor details

Research and Knowledge Exchange M402 Melbury House
1 - 3 Oxford Road
Bournemouth
BH8 8ES
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

Wessex Integrated Clinical Academic Training Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Submission of Literature Review and Protocol imminent. Results and findings to be published in 2019.

IPD sharing statement
The BALL Trial deindentified and anonymised data will be stored in the Bournemouth Online Data Repository (BORDaR) https://bordar.bournemouth.ac.uk/ .Data will available for anyone following the conclusion of the researcher’s doctorate programme in 2019 and retained for 5 years according to the University Data Management regulations.

Intention to publish date

31/12/2019

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes