Contraceptive Use After Emergency ContraceptionNCT01738971
Initiating Contraception After Emergency Contraception From Pharmacy
A study testing rapid access and one month progestogen only pill in people with Contraceptive Use After Emergency Contraception, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Contraceptive Use After Emergency Contraception
- What is being tested?
- rapid access and one month progestogen only pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- age >= 16 yrs
- requesting emergency contraception
- eligible for emergency contraception
- written , informed consent
Who cannot join
- age < 16 yrs
- not able to give written , informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chalmers sexual and reproductive health service
Edinburgh, Lothian, EH39ES
About this study
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
Read more
- Pharmacists would provide one packet of progestogen-only pills, giving women one month to arrange an appointment with contraceptive services.
- 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.
Read the detailed description
The investigators propose to test 2 pharmacy based interventions to increase uptake of effective contraception after EC:
- 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.
- 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).
- Being tested
- rapid access, one month progestogen only pill
- Keywords
- emergency contraception, community pharmacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid accessOther
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).
one month progestogen only pillOther
Also called Norgeston (Bayer, UK)
Provision of 1 month supply of a progestogen only pill (levonorgestrel 35mcg - Norgeston, Bayer, UK)
| Study group | Role | What they receive |
|---|---|---|
| control (standard care) | No intervention | standard verbal and written advice on contraception from pharmacy |
| rapid access | Experimental | rapid access to family planning service Receives: Other: rapid access |
| progestogen only pill | Experimental | one month progestogen only pill Receives: Other: one month progestogen only pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-8 weeks after EC
Secondary outcomes (3)
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.
Measured: 8 months
Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc)
Measured: 8 months
Proportion of Women Who Agree to Participate Who Can be Successfully Contacted
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Contraceptive Use After Emergency ContraceptionStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Sharon T Cameron, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738971
- Sponsor's protocol ID
- Protocol ECfe03
- Other IDs
- 182.
- Status last verified
- Aug 2014
- First submitted
- 28 Nov 2012
- Last updated
- 18 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacy Based Interventions for Initiating Effective Contraception Following the Use of Emergency Contraception : a Feasibility Study
- ClinicalTrials.gov ID
- NCT01738971
- Acronym / sponsor ID
- Protocol ECfe03
- Keywords
- emergency contraception, community pharmacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian, London School of Hygiene and Tropical Medicine
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Posted 18 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Pharmacists would provide one packet of progestogen-only pills, giving women one month to arrange an appointment with contraceptive services.
- 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.
Detailed description
The investigators propose to test 2 pharmacy based interventions to increase uptake of effective contraception after EC:
- 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.
- 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control (standard care) | No intervention | –standard verbal and written advice on contraception from pharmacy |
| rapid access | Experimental | Other: rapid accessrapid access to family planning service |
| progestogen only pill | Experimental | Other: one month progestogen only pillone month progestogen only pill |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age >= 16 yrs
- requesting emergency contraception
- eligible for emergency contraception
- written , informed consent
Key exclusion criteria (2 listed)
- age < 16 yrs
- not able to give written , informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapid accessProvision 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). | Other | rapid access |
| one month progestogen only pillAlso: Norgeston (Bayer, UK)Provision of 1 month supply of a progestogen only pill (levonorgestrel 35mcg - Norgeston, Bayer, UK) | Other | progestogen only pill |
Primary outcome
Self-reported Uptake of Effective Ongoing Contraception (Not Condoms)
Time frame: 6-8 weeks after EC
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.
3 secondary outcomes
Pharmacy Recruitment Rates
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon T Cameron, MBChB principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rapid access and one month progestogen only pill in people with Contraceptive Use After Emergency Contraception, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) (time frame: 6-8 weeks after EC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2014.