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. 2019 Oct 30;9(10):e029978.
doi: 10.1136/bmjopen-2019-029978.

Pragmatic cluster randomised cohort cross-over trial to determine the effectiveness of bridging from emergency to regular contraception: the Bridge-It study protocol

Sharon Tracey Cameron  1   2 , Paula Baraitser  3 , Anna Glasier  4 , Lisa McDaid  5 , John Norrie  6 , Andrew Radley  7   8 , Judith M Stephenson  9 , James Trussell  10 , Claire Battison  6 , Sarah Cameron  11 , Kathleen Cowle  12 , Mark Forrest  11 , Richard Gilson  13 , Beatriz Goulao  11 , Anne Johnstone  4 , Alison McDonald  11 , Alessandra Morelli  3 , Susan Patterson  5 , Deirdre Sally  13 , Nicola Stewart  13 ; Bridge-It Study Group
Collaborators, Affiliations

Pragmatic cluster randomised cohort cross-over trial to determine the effectiveness of bridging from emergency to regular contraception: the Bridge-It study protocol

Sharon Tracey Cameron et al. BMJ Open. .

Abstract

Introduction: Oral emergency contraception (EC) can prevent unintended pregnancy but it is important to start a regular method of contraception. Women in the UK usually access EC from a pharmacy but then need a subsequent appointment with a general practitioner or a sexual and reproductive health (SRH) service to access regular contraception. Unintended pregnancies can occur during this time.

Methods and analysis: Bridge-It is a pragmatic cluster randomised cohort cross-over trial designed to determine whether pharmacist provision of a bridging supply of a progestogen-only pill (POP) plus rapid access to a local SRH clinic, results in increased uptake of effective contraception and prevents more unintended pregnancies than provision of EC alone. Bridge-It involves 31 pharmacies in three UK regions (London, Lothian and Tayside) aiming to recruit 626-737 women. Pharmacies will give EC (levonorgestrel) according to normal practice and recruit women to both intervention and the control phases of the study. In the intervention phase, pharmacists will provide the POP (desogestrel) and offer rapid access to an SRH clinic. In the control phase, pharmacists will advise women to attend a contraceptive provider for contraception (standard care).Women will be asked 4 months later about contraceptive use. Data linkage to abortion registries will provide abortion rates over 12 months. The sample size is calculated on the primary outcome of effective contraception use at 4 months (yes/no) with 90% power and a 5% level of significance. Abortion rates will be an exploratory secondary analysis. Process evaluation includes interviews with pharmacists, SRH clinicians and women. Cost-effectiveness analysis will use a healthcare system perspective and be expressed as incremental cost-effectiveness ratio.

Ethics and dissemination: Ethical approval was received from South East Scotland REC June 2017. Results will be published in peer-reviewed journals and conference presentations.

Trial registration number: ISRCTN70616901.

Keywords: contraception; emergency contraception; levonorgestrel; pharmacy; progestogen only pill; unintended pregnancy.

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Conflict of interest statement

Competing interests: AG is a member of HRA Pharma scientific advisory board. PB is a Clinical Director of the not-for profit community interest company SH:24 that provides online sexual health services in partnership with the NHS. AR received research grants, educational grants and consultancy with Gilead Research grants from Roche and BMS Educational grants from Abbvie. JN is Deputy Chair of the NIHR/HTA General Board Committee. NIHR/HTA funded this research.

Figures

Figure 1
Figure 1
Bridge-it flow chart. POP, progestogen-only pill; SRH, sexual and reproductive health.
See this image and copyright information in PMC

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