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Pregnancy and Wellbeing Study (PAWS)

Psychological approach for preventing perinatal depression antenatally ?pilot of a cluster randomised controlled trial of community midwifery training

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN72346869
Enrollment
300
Registered
2011-12-02
Start date
2010-09-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Pregnancy Pregnancy and Childbirth

Interventions

Control group: The control group CMWs will continue to provide community midwife ?care as usual?, encompassing the breadth of care currently provided by community midwives. They will be only required
CMWs will also be given active feedback and guidance on practice in their use by their tr

Sponsors

University Hospitals of Leicester (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: All pregnant women on the caseload of participating community midwives, who are also: 1. Registered by the 18th week of pregnancy 2. Over 18 years of age 3. Able to give informed consent 4. Residing in the UK and intend to remain there 6 months after the birth of the baby 5. Able to read and fully comprehend English

Exclusion criteria

Exclusion criteria: 1. Not able to give informed consent for any reason 2. Not a resident of the UK or will not remain in the UK for 6 months after the birth of the baby 3. Unable to fully comprehend and read English 4. Women who are currently in receipt of treatment from specialist mental health services

Design outcomes

Primary

MeasureTime frame
1. The proportion of Edinburgh Depression Scale (EDS) negative women (clinic researcher administered) at study entry, identified at 34-weeks as EDS (clinic researcher administered) positive (EDS =12) 2. The primary comparison will be between all EDS negative women who were under the care of CMW?s randomised to provide the intervention, versus all EDS negative women under the care of CMW?s who were randomised to provide CMW care as usual 3. To assess the feasibility of the study, randomly selected intervention group women, having completed the 34 week pilot outcome, will also be invited to take part in qualitative evaluations of the pilot with an experienced researcher. All intervention midwives will take part in a confidential focus group

Secondary

MeasureTime frame
1. The proportion of Edinburgh Depression Scale (EDS) positive women (clinic researcher administered) at study entry, identified at 34-weeks (clinic researcher administered) as remaining EDS positive (EDS =12), comparing intervention with control women 2. In all participating women the mean EDS score, state anxiety with the STAI, SF-12 score and the Agnew scale at 34 weeks of pregnancy, comparing intervention with control women 3. Qualitative information on study feasibility including participation of CMWs and study women

Countries

United Kingdom

Outcome results

None listed

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