Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
14/10/2014
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 Paul Little

ORCID ID

Contact details

Primary Medical Care Group
Faculty of Medicine
Southampton University
Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom
psl3@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

GP practices

Trial type

Other

Patient information sheet

Condition

Pregnancy and childbirth: Pregnancy

Intervention

The interactive questions were itemised, and the doctor or practice nurse posed each item to the patient and ticked the box as appropriate. If the women could not respond the correct answer was discussed. We aimed for an interactive rather than a simple didactic approach. The interactive questions took 2-5 minutes depending on the woman's level of knowledge. We used two kinds of leaflet. The first was a laminated leaflet, the size of a credit card, that contained a summary of the pill rules. The card was developed from discussions with women who took the contraceptive pill, doctors, nursing colleagues, and our advisors. The second leaflet was the latest one produced by the Family Planning Association. The leaflets were given to the women without explanation, but with a simple endorsement by the doctor or practice nurse. The management sheets and the answers to the interactive questions were all well completed.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1999

Overall trial end date

31/12/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 18-45 years attending check up appointment for repeat prescription of the combined contraceptive pill.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Aged 17 or under, owing to the sensitivity of collecting the postal outcome measures
2. Unable to complete the questionnaire (learning disability, schizophrenia, major current manic or depressive episode, or both)
3. or if the consultation was their first for the contraceptive pill (this created the ethical dilemma of randomising such patients to a control group where they would receive no education on the pill rules)

Recruitment start date

01/01/1999

Recruitment end date

31/12/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Care Group
Southampton
SO16 5ST
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 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

2001 results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11477055

Publication citations

  1. Results

    Little P, Griffin S, Dickson N, Sadler C, Kelly J, Unwanted pregnancy and contraceptive knowledge: identifying vulnerable groups from a randomized controlled trial of educational interventions., Fam Pract, 2001, 18, 4, 449-453.

Additional files

Editorial Notes