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Boston migraine and contraception study

Deborah Bartz, Planned Parenthood League of Massachusetts, 2010
See also executive summary.

Project abstract

Background: Over one quarter of reproductive-age women experience migraine, a condition disabling over 12 million American women annually. Hormonal contraception (HC), used by 20 million women, may cause or aggravate migraine, leading to contraceptive discontinuation. However, scientific evidence linking HC and migraine is poor.

Objective: Using innovative real-time email messaging linked to online questionnaires, this study will generate reliable estimates of migraine incidence, prevalence, persistence and clinical impact in new users of HCs compared to users of other contraceptive methods.

Methods: A collaborating team of gynecologists, neurologists, and informaticists, we will electronically follow women starting contraception at Planned Parenthood, Boston. The three study populations—estrogen-based HC, progesterone-only HC, and non-hormonal users—will be assessed for baseline headache using established criteria and validated instruments. Computer generated reminders sent via email and innovative real-time messaging linked to online questionnaires embedded in daily emails will allow subjects to accurately track daily headaches and contraceptive use. Contraception compliance and frequency, disability, and impact of headache will be evaluated daily over three months. For the primary outcome, we will compare the change in headache frequency from baseline between the estrogen-based HC and control group and between the progesterone-only HC and control group by modeling the change as an outcome in a mixed model analysis, adjusting for baseline headache frequency and potential confounders.

Implications: This study could change the lives of millions of American women seeking contraception. This innovative electronic data collection method should increase compliance and can be applied to many future studies. Most importantly, we will be able to counsel our reproductive age patients seeking contraception more accurately on the risk of new or worsening migraine as a contraceptive side effect.

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