The POOL study: establishing the safety of waterbirth for mothers and babies

Not Applicable

• Conditions: Birth in water following water immersion during labour; Pregnancy and Childbirth

• Registration Number: ISRCTN13315580
• Lead Sponsor: Cardiff University

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33419905/ protocol (added 11/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-04
• Last Update Posted: 27 February 2024
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 52410

Inclusion Criteria

Current participant inclusion criteria as of 09/09/2022:
1. Women, and their infants, if the woman used water immersion at a study site during the period of data collection
2. Any women for whom water immersion analgesia is recorded in Wellbeing Software’s E3 system
3. Birth in which the foetus is partially or totally expelled under water

Previous participant inclusion criteria:
Routine Data Work Package: Women who meet NICE criteria for ‘low risk’ and who use a pool (water immersion) during labour

Qualitative Work Package: [online stakeholder discussion groups]
1. Heads of Midwifery / Midwifery Managers from study sites
2. Consultant Midwives from study sites
3. Band 5/6 clinically focused midwives
4. UK Obstetricians from within and outside of study sites (accessed via RCOG or another route)
5. UK Neonatologists from within and outside of study sites (accessed via the UK Neonatal Collaborative (UKNC) the RCPCH or another route
6. Public including members of the RCOG Women’s group, with participation open to women at study and non-study sites

Exclusion Criteria

Excluded from data analysis: Data relating to women and babies recorded in EuroKing as being ‘Born Before Arrival’ (BBA), or recorded as intentionally born without midwifery attendance, will be excluded from primary analysis as well as those who opt-out from the study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal primary outcome measure:<br>Obstetric Anal Sphincter Injuries (OASIS), measured using routinely collected maternal data (EUROKING) at birth<br><br>Neonatal primary outcome measure:<br>Composite outcome of ‘adverse neonatal outcomes or treatment:<br>1. Any neonatal unit admission requiring respiratory support, measured using routinely collected neonatal data (NNRD) at hospital discharge<br>2. Antibiotic administration within 48 hours of birth (with or without culture proven infection), measured using routinely collected maternal data (EUROKING) at hospital discharge<br>3. Intrapartum stillbirth or neonatal death, measured using routinely collected maternal data (EUROKING) at hospital discharge