Condition category
Pregnancy and Childbirth
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

2003 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/14622490

Publication citations

  1. 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.

Additional files

Editorial Notes