Contact information
Type
Scientific
Primary contact
Dr T G Heyes
ORCID ID
Contact details
The Health Centre
Church Street
Darton
Barnsley
S75 5HQ
United Kingdom
+44 (0)1226 382420
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RBH 97XX5
Study information
Scientific title
A randomised controlled trial of a preconception clinic in Barnsley
Acronym
Study hypothesis
What is the clinical effectiveness of providing preconception care in Barnsley to couples with a history of adverse pregnancy outcomes?
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: Pregnancy
Intervention
1. Preconception care
2. No care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
An effective means of delivering a package of preconception care, incorporating interventions of known effectiveness, which reduces the risk of adverse outcomes to pregnancy saying costs short and long term for an acceptable initial expenditure. Publication of papers in peer reviewed journals Local regional and national seminars describing the findings to clinicians and health educators in primary and secondary care. Representations to health authority to implement findings.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/1998
Overall trial end date
28/02/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Couples where woman has a recent history of miscarriage, small for dates baby, premature birth, stillbirth or congenital defect
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 in each group
Participant exclusion criteria
Women aged under 18 at the time of study
Recruitment start date
01/03/1998
Recruitment end date
28/02/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Health Centre
Barnsley
S75 5HQ
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 Trent (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 expected to be available
Results - basic reporting
Publication summary