An interventional study of rapid access and one month progestogen only pill in Contraceptive Use After Emergency Contraception, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to female participants aged 16 Years to 45 Years. Per ClinicalTrials.gov, last updated 2014-08-18.
Sponsored by University of Edinburgh · Not applicable, Interventional, and Health services research
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
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.
The investigators propose to test 2 pharmacy based interventions to increase uptake of effective contraception after EC:
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).
1,692 studies on the registry are indexed under Emergencies; 332 are open to participants now.
This study's enrollment of 168 is above the median of 145 across 930 interventional studies indexed under Emergencies.
Browse Emergencies studies →University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
standard verbal and written advice on contraception from pharmacy
rapid access to family planning service
Other: rapid access
one month progestogen only pill
Other: one month progestogen only pill
Provision of box which the participant can take to local family planning clinic (contraceptive service) allowing rapid access (i.e. will be seen by a health professional for a consultation regarding contraception there and then).
Provision of 1 month supply of a progestogen only pill (levonorgestrel 35mcg - Norgeston, Bayer, UK)
Also known as: Norgeston (Bayer, UK)
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.
Time frame: 6-8 weeks after EC
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.
Time frame: 8 months
Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc)
Time frame: 8 months
Proportion of Women Who Agree to Participate Who Can be Successfully Contacted
Time frame: 8 months
Qualitative Outcomes : Women's Views on Different Measures to Determine Validity of Self-reported Data on Contraceptive Use , Determined by in Depth Interviews.
Time frame: 8 months
Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties
Time frame: 12 months
Recruitment from end April 2012 - end December 2012 (8 month period). Recruitment of participants by community pharmacists within 11 community pharmacies in Edinburgh. All participating pharmacists trained by the research team prior to commencing recruitment of participants.
| Milestone | Control (Standard Care) | Rapid Access | Progestogen Only Pill |
|---|---|---|---|
| Started | 54 | 58 | 56 |
| Completed | 35 | 28 | 39 |
| Not completed | 19 | 30 | 17 |
| Withdrew: Lost to follow-up | 19 | 30 | 17 |
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.
| participants | Control (Standard Care) | Rapid Access | Progestogen Only Pill |
|---|---|---|---|
| Effective contraception | 5 | 13 | 22 |
| Long acting contraception | 0 | 5 | 3 |
| No contraception / barrier method | 26 | 12 | 17 |
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.
| participants | Control (Standard Care) | Rapid Access | Progestogen Only Pill |
|---|---|---|---|
| Recruited | 54 | 58 | 56 |
| Not recruited from target figure | 6 | 2 | 4 |
Results for this outcome have not been posted.
| participants | Control (Standard Care) | Rapid Access | Progestogen Only Pill |
|---|---|---|---|
| Women successfully contacted for follow-up | 35 | 28 | 39 |
| Not contacted / lost to follow-up | 19 | 30 | 17 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 14 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control (Standard Care) | — | 0/54 (0%) | 0/54 (0%) |
| Rapid Access | — | 0/58 (0%) | 0/58 (0%) |
| Progestogen Only Pill | — | 0/56 (0%) | 0/56 (0%) |
Baseline analysis conducted on all participants successfully contacted for telephone follow-up at 6-8weeks post enrollment to study. no baseline analysis possible on those recruited in pharmacy but lost to follow-up.
| Age, Continuous(years) | Control (Standard Care) | Rapid Access | Progestogen Only Pill | Total |
|---|---|---|---|---|
| Mean | 23 ± 4.5 | 25 ± 5.6 | 22 ± 5.2 | 23 ± 5.2 |
| Sex: Female, Male(Participants) | Control (Standard Care) | Rapid Access | Progestogen Only Pill | Total |
|---|---|---|---|---|
| Female | 35 | 28 | 39 | 102 |
| Male | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control (Standard Care) | Rapid Access | Progestogen Only Pill | Total |
|---|---|---|---|---|
| United Kingdom | 35 | 28 | 39 | 102 |
| Contraception use at time of enrollment(participants) | Control (Standard Care) | Rapid Access | Progestogen Only Pill | Total |
|---|---|---|---|---|
| None | 12 | 8 | 13 | 33 |
| Condoms | 19 | 17 | 26 | 62 |
| Other method | 4 | 3 | 0 | 7 |
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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