The costs and benefits of post-natal midwifery support - a randomised controlled trial
| ISRCTN | ISRCTN15493767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15493767 |
| Protocol serial number | HTA 94/22/24 |
| 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
- 27/08/2009
- 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
Ms Jane Morrell
Scientific
Scientific
Institute of General Practice and Primary Care
University of Sheffield
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
| Phone | +44 (0)114 249 2500 |
|---|---|
| j.morrell@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
The primary outcome was the general health perception domain of the Short Form-36 at 6 weeks. |
| Key secondary outcome measure(s) |
Secondary outcomes were mean Edinburgh Postnatal Depression Scale (EPDS), Duke Functional Social Support (DUFSS) scores and breastfeeding rates. |
| Completion date | 31/08/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/06/1996 |
| Date of final enrolment | 31/08/1998 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute of General Practice and Primary Care
Sheffield
S5 7AU
United Kingdom
S5 7AU
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/09/2000 | Yes | No | |
| Other publications | HTA monograph | 01/02/2000 | Yes | No |
