Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
07/09/2015
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 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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes