Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
26/01/2010
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

Dr David Jewell

ORCID ID

Contact details

University of Bristol
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom
+44 (0)117 928 7308
David.Jewell@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C/PHI/19/20-6-94/JEWELL/D

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study was to assess the effect of encouraging women to decide the frequency and timing of their antenatal attendances within a framework of a reduced number of prescribed attendances. The main hypothesis was: adopting a more flexible approach to antenatal care would result in an increase in maternal satisfaction.

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

Other

Trial type

Other

Patient information sheet

Condition

Pregnancy; antenatal care

Intervention

1. 'Traditional' care
2. 'Flexible' care

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Women's attitudes to pregnancy and motherhood, measured by one subscale of the Maternal Adjustment and Maternal Attitudes questionnaire (MAMA)
2. Satisfaction with antenatal care
3. Perception of the speed of recognition of antenatal complications.
4. The amount of antenatal care received was used as a measure of process
5. The prevalence of depression was measured using the Edinburgh Postnatal Depression Scale (EPDS)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1995

Overall trial end date

30/11/1998

Reason abandoned

Eligibility

Participant inclusion criteria

Pregnant women at low risk of obstetric outcomes

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

609 (added 26/01/10; see publication)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/06/1995

Recruitment end date

30/11/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 2PR
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (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 results in http://www.ncbi.nlm.nih.gov/pubmed/11028575

Publication citations

  1. Results

    Jewell D, Sharp D, Sanders J, Peters TJ, A randomised controlled trial of flexibility in routine antenatal care., BJOG, 2000, 107, 10, 1241-1247.

Additional files

Editorial Notes