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

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

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

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

  1. 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.

  2. 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.

Additional files

Editorial Notes