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The Ball Assisted Latent Labour trial

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10755909
Enrollment
332
Registered
2018-05-10
Start date
2018-02-01
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain in the latent phase of labour Pregnancy and Childbirth Pain during labour

Interventions

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 rece

Sponsors

Bournemouth University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, United Kingdom

Contacts

Public ContactDominique Mylod
dmylod@bournemouth.ac.uk07799883514

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026