ISRCTN ISRCTN28035939
DOI https://doi.org/10.1186/ISRCTN28035939
Protocol serial number RBH 97XX5
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
Funder NHS Executive Trent (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
07/09/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr T G Heyes
Scientific

The Health Centre
Church Street
Darton
Barnsley
S75 5HQ
United Kingdom

Phone +44 (0)1226 382420
Email abc@email.com

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleA randomised controlled trial of a preconception clinic in Barnsley
Study objectivesWhat is the clinical effectiveness of providing preconception care in Barnsley to couples with a history of adverse pregnancy outcomes?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPregnancy and childbirth: Pregnancy
Intervention1. Preconception care
2. No care
Intervention typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date28/02/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration200
Key inclusion criteriaCouples where woman has a recent history of miscarriage, small for dates baby, premature birth, stillbirth or congenital defect
Key exclusion criteriaWomen aged under 18 at the time of study
Date of first enrolment01/03/1998
Date of final enrolment28/02/2001

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

The Health Centre
Barnsley
S75 5HQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
IPD sharing plan