Contact information
Type
Scientific
Primary contact
Prof Christine MacArthur
ORCID ID
Contact details
Dept of Public Health & Epidemiology
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 0121 414 6770
C.MacArthur@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 94/22/26
Study information
Scientific title
Acronym
Study hypothesis
Recent government reports have highlighted the need for change in the provision of maternity care. The objective of this study is to develop and implement two new models of postnatal care. The cost-effectiveness of the models will be compared with current practice in a three arm randomised controlled trial. The new models will comprise midwifery-led protocol-based care, aimed at the identification and management of individual women's physical and psychological health problems. They are designed to make more appropriate use of the skills and time of the professionals involved. The role of the midwife will be extended to undertake the postnatal examination, with GP referral based on need. The content and frequency of postnatal consultations will be substantially modified and there will be a reduction in routine monitoring, observations and examinations. In one intervention arm the new model of care will extend until three months postpartum. The findings will have direct implications for delivery of care throughout the National Health Service.
Ethics approval
Not provided at time of registration.
Study design
Cluster 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
Childbirth
Intervention
1. New model of community care
2. Standard community post natal care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Outcomes will be assessed by measures of physical and emotional well-being and satisfaction with care.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/05/1996
Overall trial end date
31/03/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Consenting cluster practices
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
2,064
Participant exclusion criteria
Women expected to move out of the general practice in the post-natal period.
Recruitment start date
01/05/1996
Recruitment end date
31/03/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept of Public Health & Epidemiology
Birmingham
B15 2TT
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
Basic results (scientific)
Publication list
2003 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/14622490
Publication citations
-
HTA monograph
MacArthur C, Winter HR, Bick DE, Lilford RJ, Lancashire RJ, Knowles H, Braunholtz DA, Henderson C, Belfield C, Gee H, Redesigning postnatal care: a randomised controlled trial of protocol-based midwifery-led care focused on individual women's physical and psychological health needs., Health Technol Assess, 2003, 7, 37, 1-98.