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
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
-
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.