Recommendations for standardization of bleeding data analyses in contraceptive studies.

To address limitations that exist with existing definitions of menstrual bleeding changes that occur with contraceptive methods, we assembled a panel to develop new recommendations for standardization of bleeding data analyses associated with contraceptive use to better inform users, clinicians, investigators, pharmaceutical companies, and regulatory agencies. We propose three criteria for assessing bleeding outcomes: pattern, flow, and duration. The descriptors within each criterion depend on whether the contraceptive is designed to result in a predictable or unpredictable bleeding pattern. Predictable pattern outcomes quantify days of scheduled, unscheduled and no bleeding, while unpredictable pattern outcomes assess frequency. Flow is quantified based on patient comparisons to their typical flow when not using contraception, with spotting representing no menstrual products use. Duration of a prolonged bleeding and/or spotting episode is more than 7 days. Studies should assess bleeding characteristics for a minimum of 12 months for 21/7, 24/4, extended cycle or continuous regimens, two years for injectables, and the full duration of use for long-acting contraceptives. Describing pattern, flow and duration as independent categories allows a fuller understanding of the bleeding outcomes and better future assessments of acceptability and continuation. Standardization of outcomes permits better comparison between studies and data synthesis; standardization will also improve the ability of clinicians and patients to understand differences between products.

Copper IUD continuation, unwanted effects and cost consequences at 1 year in users aged under 30 - a secondary analysis of the EURAS-IUD study.

OBJECTIVE: To conduct a secondary analysis of continuation, unwanted effects and cost consequences at 1 year in copper intrauterine device (IUD) users aged under 30 in the European Active Surveillance Study for Intrauterine Devices (EURAS-IUD study) based on IUD type. METHODS: Descriptive and comparative analyses of copper IUD continuation, unwanted effects and estimated cost consequences at 1 year were performed in users aged under 30 based on IUD copper surface area, shape or design, width and arms' flexibility. RESULTS: 5796 copper IUD users were identified to have been aged under 30 at EURAS-IUD study recruitment and data for 5762 users (99.4%) was analysed. Higher IUD continuation, fewer unwanted effects and lower costs were observed with IUDs of the lowest copper content (<300mm2), horse-shoe frame design, widths 18 mm to <30mm and flexible IUD arms. Discontinuation, unwanted effects and costs were greater with frameless IUDs and framed, ≥30mm width IUDs with 380mm2 of copper and copper bands on their rigid transverse IUD arms. CONCLUSIONS: Significant differences in continuation, reported unwanted effects and estimated costs at 1 year between IUD types were observed in users aged under 30. Although further research is needed, clinicians should consider these findings when counselling and choosing IUD types for younger women.

Improving uptake of the copper intrauterine device for emergency contraception by educating pharmacists in the community.

OBJECTIVES: The copper intrauterine device (Cu-IUD) is the most effective method of emergency contraception (EC) and provides ongoing contraception, yet few women choose this option. This study evaluates the impact of an educational initiative involving pharmacists on uptake of Cu-IUDs for EC in an integrated sexual health clinic in the North East of England. METHODS: Since November 2010, local pharmacists have received intensive education detailing EC options including Cu-IUDs. At the same time a rapid access referral pathway for fitting of an emergency Cu-IUD was established. The impact of this initiative has been assessed by analysing case notes of women attending a large city centre sexual health service who received an emergency Cu-IUD during September and October 2010 (prior to the initiative) and the same 2 months in 2011 (9 months after the start of the intervention). RESULTS: The number of women fitted with an emergency Cu-IUD increased by almost three-fold from 11 fitted in September and October 2010 to 30 fitted in these 2 months in 2011. One woman was referred from a pharmacist to the service in the first audit period compared with 17 in the second. No pregnancies occurred in the first month after Cu-IUD insertion in these 41 women. CONCLUSIONS: Educating pharmacists has increased referral and uptake of Cu-IUD used for EC and this has the potential to reduce unintended pregnancies now and in the future.