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

Establishing the safety of waterbirth for mothers and babies: a cohort study with nested qualitative component

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13315580
Enrollment
46200
Registered
2018-05-04
Start date
2018-06-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Birth in water following water immersion during labour Pregnancy and Childbirth

Interventions

Current interventions as of 09/09/2022: Summary of methodology: A natural experiment using a cohort design with a nested qualitative component will answer the study objectives by using a combination
data will be gathered in online discussion groups, focus groups and one-to-one interviews with key stakeholders, including women. To answer all research objectives approximately 600,000 individual c

Sponsors

Cardiff University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Current secondary outcome measures as of 09/09/2022: Maternal secondary outcome measures: 1. Maternal intrapartum: shoulder dystocia and required management, management of the third stage of labour, need and reason for obstetric involvement in woman’s care, maternal position at birth, treatment for haemorrhage, incidence and management of perineal and other genital trauma. Measured using routinely collected maternity data (EUROKING) at birth. 2. Maternal postnatal: duration of postnatal stay, breastfeeding initiation and continuation, higher level care, and maternal readmission to the hospital within 7 days of birth. Measured using routinely collected maternity data (EUROKING) at hospital discharge. 3. Lumbar puncture, culture-proven infection, brachial plexus injury, treatment for jaundice, therapeutic hypothermia, measured using routinely collected maternity data (EUROKING) at hospital discharge Infant secondary outcome measures: 1. Timing of cord clamping measured using routinely collected maternity data (EUROKING) at birth 2. Apgar scores measured using routinely collected maternity data (EUROKING) at birth 3. Resuscitation measured using routinely collected maternity data (EUROKING) at birth 4. Intrapartum stillbirth or all deaths prior to neonatal unit/postnatal ward discharge measured using routinely collected neonatal and maternity data (NNRD, EUROKING) at birth and hospital discharge 5. Neonatal deaths that occurred within seven days of birth on a neonatal unit/postnatal ward measured using routinely collected maternity data (EUROKING) at birth, during admission or during readmission 6. Snapped umbilical cord prior to clamping measured using routinely collected maternity data (EUROKING) at birth 7. Skin-to-skin contact at birth measured using routinely collected maternity data (EUROKING) at birth 8. First breastfeed within the first hour measured using routinely collected maternity data (EUROKING) at birth 9. Administration of intravenous antibiotics in

Countries

United Kingdom, Wales

Contacts

Public ContactRebecca;Christy Milton;Barlow

;

miltonrl1@cardiff.ac.uk;BarlowC2@cardiff.ac.uk+44 (0)29206 87612;+44 (0)2920 687174

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026