Pregnancy and Wellbeing Study (PAWS)

Not Applicable

Completed

Conditions: Pregnancy
Pregnancy and Childbirth

Registration Number: ISRCTN72346869

Lead Sponsor: niversity Hospitals of Leicester (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 300

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>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<br>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 Outcome Measures

Name	Time	Method
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<br>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<br>3. Qualitative information on study feasibility including participation of CMWs and study women