Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Maternal Use of Oral Contraceptives

Is there a risk of birth defects?

No increased risk of any major birth defect associated with oral contraceptive (OC) exposure just before or during pregnancy was observed in a cohort study of 800,694 live births. After 1 year follow-up, researchers found:

• Prevalence of major birth defects was consistent across each oral contraceptive group.

• No increase in prevalence of major birth defects was seen in OC exposure among women with recent use before pregnancy (OR=0.98) or use after pregnancy onset (OR=0.84), compared with the reference group.

• There was no increase in prevalence of any birth defect subgroup.

Citation: Charlton BM, Mølgaard-Nielsen D, Svanström, Wohlfahrt J, Pasternak B, Melbye M. Maternal use of oral contraceptives and risk of birth defects in Denmark: prospective, nationwide cohort study. BMJ 2016;352:h6712. doi: http://dx.doi.org/10.1136/bmj.h6712.

Commentary: When used perfectly, without missing any pills, OCs have a failure rate of 0.3% (0.3 women per 100 women who us the method per year), but have a typical user failure rate of 8%.1 This means that about 8% of typical OC users will become pregnant in the first year of use. This prospective observational cohort study looked at over three-quarters of a million live births from Danish registries between 1997 and 2011 and compared those whose mothers never used OC, used OC > 3 months prior to pregnancy onset, 0-3 months before pregnancy onset, and use after pregnancy onset. It is reassuring to see that there is not an increase in risk of birth defects with OC use just before or during early pregnancy. —Neil Skolnik, MD

1. Centers for Disease Control and Prevention. United States Medical Eligibility Criteria (US MEC) for Contraceptive Use, 2010. CDC Web site. http://www.cdc.gov/reproductivehealth/UnintendedPregnancy/USMEC.htm. Accessed January 18, 2016.