A randomised trial of educational interventions for women taking the combined oral contraceptive pill (COCP)

ISRCTN	ISRCTN22671317
DOI	https://doi.org/10.1186/ISRCTN22671317
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Dr Paul Little
Scientific

Primary Medical Care Group
Faculty of Medicine
Southampton University
Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom

Email	psl3@soton.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Other
Scientific title
Study hypothesis	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1999
Overall study end date	31/12/1999

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	Female
Target number of participants	Not provided at time of registration
Participant inclusion criteria	Women aged 18-45 years attending check up appointment for repeat prescription of the combined contraceptive pill.
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

Primary Medical Care Group

Southampton
SO16 5ST
United Kingdom

NHS R&D Regional Programme Register - Department of Health (UK)
Government

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

Government

NHS Executive South West (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2001		Yes	No