Contact information
Type
Scientific
Primary contact
Ms Jane Morrell
ORCID ID
Contact details
Institute of General Practice and Primary Care
University of Sheffield
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 (0)114 249 2500
j.morrell@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 94/22/24
Study information
Scientific title
Acronym
Study hypothesis
This study aimed to measure the effect and the total cost per woman of providing postnatal support at home, based on a Dutch model. The research hypothesis was furnished by some existing evidence that postnatal support could reduce the risk of postnatal depression and encourage breastfeeding.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Pregnancy and childbirth: Childbirth
Intervention
The randomised controlled trial aimed to measure differences in health status in a group of women who were offered postnatal support from a community midwifery support worker (SW) compared with a control group of women who were not offered this support. Women were followed-up by postal questionnaire at 6 weeks and 6 months postnatally.
The intervention consisted of the SW offering practical and emotional support and to help women rest and recover after childbirth. The SW offered ten visits in the first 28 days postnatally, for up to 3 hours per day. The SW's activities included housework, talking with the mother, and care for the baby or other siblings. The service was provided in addition to routine visits by the community midwife.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome was the general health perception domain of the Short Form-36 at 6 weeks.
Secondary outcome measures
Secondary outcomes were mean Edinburgh Postnatal Depression Scale (EPDS), Duke Functional Social Support (DUFSS) scores and breastfeeding rates.
Overall trial start date
01/06/1996
Overall trial end date
31/08/1998
Reason abandoned
Eligibility
Participant inclusion criteria
All women who delivered a baby at the recruiting hospital were eligible to take part in the trial if they lived within the study area, were aged 17 years or over, and could understand English.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration.
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/06/1996
Recruitment end date
31/08/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of General Practice and Primary Care
Sheffield
S5 7AU
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2000 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/10858637
2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10977833
Publication citations
-
HTA monograph
Morrell CJ, Spiby H, Stewart P, Walters S, Morgan A, Costs and benefits of community postnatal support workers: a randomised controlled trial., Health Technol Assess, 2000, 4, 6, 1-100.
-
Results
Morrell CJ, Spiby H, Stewart P, Walters S, Morgan A, Costs and effectiveness of community postnatal support workers: randomised controlled trial., BMJ, 2000, 321, 7261, 593-598.