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J Am Board Fam Med. 2012 Sep-Oct;25(5):661-8.

Contraceptive methods and informed consent among women receiving medications with potential for adverse fetal effects: a Washington, Wyoming, Alaska, Montana, Idaho (WWAMI) region study.

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Department of Family Medicine, Idaho State University, Pocatello, ID, USA.



Increasing diabetes, hypertension, and hypercholesterolemia rates expose some young women to medications with potential adverse fetal effects, such as angiotensin-converting enzyme inhibitors (ACE-Is), angiotensin receptor blockers (ARBs), and statins. This study examined whether quality improvement (QI) interventions promote informed consent and contraception to minimize risks with use of ACE-I/ARB/statins.


This longitudinal cohort study at 7 clinics abstracted medical records of 328 women aged 18 to 44 with ≥1 prescription for ACE-I/ARB/statins and ≥1 visit for hypertension, diabetes, or hypercholesterolemia during the previous year. We measured informed consent documentation and contraceptive methods before and after QI interventions in which providers contacted their patients to discuss medication risks and benefits.


Of 179 women who were not surgically sterilized, only 11.7% had documented informed consent related to the risks of ACE-I/ARB/statin use. One hundred fifty-eight women were eligible for the QI intervention (not surgically sterilized, no documented informed consent); only 76 (48.1%) received the intervention. Before the intervention, 23.7% of these 76 were "at risk" of an adverse fetal effect. After the intervention, only 7.9% (P ≤ .001) were "at risk" because some women started contraception, discontinued ACE-I/ARB/statins, or changed drug class.


Women prescribed ACE-I/ARB/statins were not consistently using contraception or were not consistently informed of the risks. Provider-implemented QI interventions improved care but were difficult to accomplish, suggesting that new interventions are needed.

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