Redesigning postnatal care: a randomised controlled trial of protocol-based, midwifery-led care
| ISRCTN | ISRCTN79350792 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79350792 |
| Protocol serial number | HTA 94/22/26 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 01/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Christine MacArthur
Scientific
Scientific
Dept of Public Health & Epidemiology
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 0121 414 6770 |
|---|---|
| C.MacArthur@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Redesigning postnatal care: a randomised controlled trial of protocol-based, midwifery-led care |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Childbirth |
| Intervention | 1. New model of community care 2. Standard community post natal care |
| Intervention type | Other |
| Primary outcome measure(s) |
Outcomes will be assessed by measures of physical and emotional well-being and satisfaction with care. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 31/03/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 2064 |
| Total final enrolment | 2064 |
| Key inclusion criteria | Consenting cluster practices |
| Key exclusion criteria | Women expected to move out of the general practice in the post-natal period. |
| Date of first enrolment | 01/05/1996 |
| Date of final enrolment | 31/03/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Dept of Public Health & Epidemiology
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/01/2003 | Yes | No |
Editorial Notes
01/04/2022: The following changes have been made:
1. Publication reference reclassified as results.
2. The final enrolment number has been added from the reference.
