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Initiating Contraception After Emergency Contraception From Pharmacy

U

University of Edinburgh

Status

Completed

Conditions

Contraceptive Use After Emergency Contraception

Treatments

Other: rapid access
Other: one month progestogen only pill

Study type

Interventional

Funder types

Other

Identifiers

NCT01738971
182. (Other Identifier)
Protocol ECfe03

Details and patient eligibility

About

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.

Full description

The investigators propose to test 2 pharmacy based interventions to increase uptake of effective contraception after EC:

  1. Pharmacists would provide one packet of progestogen-only pills to women, so that they would have 28 days to arrange an appointment with contraceptive services to get a supply of ongoing contraception.
  2. Rapid access to a family planning clinic upon presentation of their empty(used) packet of EC. Women would be seen as a 'walk-in' (without appointment) and ongoing contraception discussed and provided.

These interventions would be compared with the status quo, i.e. pharmacists give verbal advice and written information on local contraceptive services where ongoing contraception can be accessed.

The interventions that we are testing are low cost i.e one packet of progestogen-only pills (£3 for most costly brand) plus additional consultation time with the pharmacist (estimated 20 mins@ £1 per minute), versus the staff consultation time in a family planning clinic. In the family planning clinic, women would be seen as a 'walk-in' and so this may not add costs, since staff are already present.These interventions could, if shown to be effective, offer huge costs savings to the NHS, by reducing the costs of unintended pregnancies (abortion, miscarriage, birth).

Enrollment

168 patients

Sex

Female

Ages

16 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

168 participants in 3 patient groups

control (standard care)
No Intervention group
Description:
standard verbal and written advice on contraception from pharmacy
rapid access
Experimental group
Description:
rapid access to family planning service
Treatment:
Other: rapid access
progestogen only pill
Experimental group
Description:
one month progestogen only pill
Treatment:
Other: one month progestogen only pill

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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