COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Initiating Contraception After Emergency Contraception From Pharmacy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01738971
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : August 18, 2014
Last Update Posted : August 18, 2014
NHS Lothian
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
University of Edinburgh

Brief 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 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.

Condition or disease Intervention/treatment Phase
Contraceptive Use After Emergency Contraception Other: rapid access Other: one month progestogen only pill Not Applicable

Detailed 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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pharmacy Based Interventions for Initiating Effective Contraception Following the Use of Emergency Contraception : a Feasibility Study
Study Start Date : April 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
No Intervention: control (standard care)
standard verbal and written advice on contraception from pharmacy
Experimental: rapid access
rapid access to family planning service
Other: rapid access
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).

Experimental: progestogen only pill
one month progestogen only pill
Other: one month progestogen only pill
Provision of 1 month supply of a progestogen only pill (levonorgestrel 35mcg - Norgeston, Bayer, UK)
Other Name: Norgeston (Bayer, UK)

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Pharmacy Recruitment Rates [ Time Frame: 8 months ]
    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.

  2. Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc) [ Time Frame: 8 months ]
  3. Proportion of Women Who Agree to Participate Who Can be Successfully Contacted [ Time Frame: 8 months ]

Other Outcome Measures:
  1. 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 ]
  2. Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01738971

Layout table for location information
United Kingdom
Chalmers sexual and reproductive health service
Edinburgh, Lothian, United Kingdom, EH39ES
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
London School of Hygiene and Tropical Medicine
Layout table for investigator information
Principal Investigator: Sharon T Cameron, MBChB University of Edinburgh

Layout table for additonal information
Responsible Party: University of Edinburgh Identifier: NCT01738971    
Other Study ID Numbers: Protocol ECfe03
182. ( Other Identifier: Edinburgh and Lothians Health Foundation )
First Posted: November 30, 2012    Key Record Dates
Results First Posted: August 18, 2014
Last Update Posted: August 18, 2014
Last Verified: August 2014
Keywords provided by University of Edinburgh:
emergency contraception
community pharmacy
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease Attributes
Pathologic Processes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral