Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
13/10/2014
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 Jill Morrison

ORCID ID

Contact details

Department of General Practice
University of Glasgow
4 Lancaster Crescent
Glasgow
G12 0RR
United Kingdom
+44 (0)141 211 1666
jmm4y@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSI02-09

Study information

Scientific title

Acronym

Study hypothesis

How do clinical guidelines affect the management of infertility in general practice? Clinical guidelines were developed locally by consensus and informed by available evidence. Their dissemination included educational meetings.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pregnancy and childbirth: Pregnancy

Intervention

The guidelines were evaluated in a cluster randomised controlled trial (RCT). General practices in the intervention arm received the guidelines and those in the control arm were told they would receive them after one year.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. The time from presentation to referral
2. Investigations completed in general practice
3. Number and content of hospital outpatient visits
4. The time to reach a management plan
5. Costs for referrals from the two groups

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1997

Overall trial end date

31/12/2000

Reason abandoned

Eligibility

Participant inclusion criteria

The sample comprised all general practices in Greater Glasgow Health Board Area (n = 621,at the beginning of the study). All referrals to each of five hospitals in Glasgow managing infertility were collected for one year.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

689

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1997

Recruitment end date

31/12/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of General Practice
Glasgow
G12 0RR
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Primary and Secondary Care Interface National Research and Development Programme (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

Results in http://www.ncbi.nlm.nih.gov/pubmed/11375232

Publication citations

  1. Results

    Morrison J, Carroll L, Twaddle S, Cameron I, Grimshaw J, Leyland A, Baillie H, Watt G, Pragmatic randomised controlled trial to evaluate guidelines for the management of infertility across the primary care-secondary care interface., BMJ, 2001, 322, 7297, 1282-1284.

Additional files

Editorial Notes