Contraceptive Use After Emergency Contraception Clinical Trial
Official title:
Pharmacy Based Interventions for Initiating Effective Contraception Following the Use of Emergency Contraception : a Feasibility Study
Pharmacists do not provide immediate contraception to women after emergency contraception
(EC); they can only give advice on local contraceptive services.
The investigators wish to establish the following 2 pharmacy- based interventions in NHS
Lothian, designed to increase uptake of effective contraception as soon as possible, after
EC
1. Pharmacists would provide one packet of progestogen-only pills, giving women one month
to arrange an appointment with contraceptive services.
2. Rapid access to a family planning clinic upon presentation of the empty EC packet.
Women would be seen as a 'walk-in' and contraception provided.
If feasible, these interventions could reduce unintended pregnancies.
Participating pharmacies will be randomised to provide one of the interventions, or standard
care (verbal/written advice on local contraceptive services).
Women requesting EC from study pharmacies will be recruited by the research nurse/doctor to
participate in the study that will involve them consenting to contact by telephone 6-8 weeks
after EC by the researcher, to evaluate the interventions in terms of :
(i) determine women's experiences/ views of the interventions and control. (ii) determine if
women have commenced effective contraception and if not , reasons why.
A subset of 12 women will also be invited for in-depth interview to collect more detailed
qualitative data on their EC experience.
The investigators also wish to (iii) explore pharmacists views on the interventions
Data from this pilot will enable the investigators to determine whether a larger multisite
study is feasible. The aims of a larger study being to determine if either of the two
interventions being tested result in an increased proportion of women using effective
ongoing contraception compared to the control.
| Status | Completed |
| Enrollment | 168 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 16 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - age >= 16 yrs - requesting emergency contraception - eligible for emergency contraception - written , informed consent Exclusion Criteria: - age < 16 yrs - not able to give written , informed consent |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Chalmers sexual and reproductive health service | Edinburgh | Lothian |
| Lead Sponsor | Collaborator |
|---|---|
| University of Edinburgh | London School of Hygiene and Tropical Medicine, NHS Lothian |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Qualitative Outcomes : Women's Views on Different Measures to Determine Validity of Self-reported Data on Contraceptive Use , Determined by in Depth Interviews. | 8 months | No | |
| Other | Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties | 12 months | No | |
| Primary | Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) | Outcome measure identified when participants conducted for agreed telephone interview 6-8 weeks following recruitment to study. Participants asked via telephone what method of contraception, if any, there were currently using. | 6-8 weeks after EC | No |
| Secondary | Pharmacy Recruitment Rates | Proportion of participants that pharmacists were successful in recruiting during the specified 8 month recruitment time period. Initial target set to recruit 60 participants to each arm/group. | 8 months | No |
| Secondary | Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc) | 8 months | No | |
| Secondary | Proportion of Women Who Agree to Participate Who Can be Successfully Contacted | 8 months | No |