Abstract

BackgroundMedications may be consumed periconceptionally before a woman knows she is pregnant. In this study, the authors evaluate the association of a prescription diet drug (Letigen) containing ephedrine (20 mg) and caffeine (200 mg) with spontaneous abortion (SAB) in the Danish National Birth Cohort.MethodsWomen were recruited during their first prenatal visit from 1996–2002. Pre-conception and early pregnancy medication use was reported on the enrollment form, and pregnancy outcome was determined by linking the mother's Civil Registration Number to the Medical Birth Registry and the National Hospital Discharge Register. Of 97,903 eligible pregnancies, 4,443 ended in SAB between 5 and 20 completed gestational weeks, inclusive. Letigen use was reported for 565 pregnancies. Cox regression models accounting for left truncation were fit to estimate the effect of pre-conception and early pregnancy Letigen use on SAB.Principal FindingsThe estimated maternal age-adjusted hazard ratio for SAB was 1.1 (95% confidence interval 0.8–1.6) for any periconceptional Letigen use compared to no periconceptional use.ConclusionsAlthough Letigen has high levels of caffeine (the recommended 3 pills/day are approximately equivalent to caffeine from 6 cups of coffee), periconceptional use does not appear to be associated with an appreciably increased hazard of clinically recognized SAB.

Highlights

  • Gestation is a critical time in fetal development when women may be unaware they are pregnant and may use medications, such as diet drugs, that they would not use knowing they were pregnant

  • Letigen has high levels of caffeine, periconceptional use does not appear to be associated with an appreciably increased hazard of clinically recognized spontaneous abortion (SAB)

  • We examine whether periconceptional Letigen use is associated with SAB in the Danish National Birth Cohort

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Summary

Introduction

Gestation is a critical time in fetal development when women may be unaware they are pregnant and may use medications, such as diet drugs, that they would not use knowing they were pregnant. There has been little research on the effects of ephedrine on pregnancy, but concern over the potential effect of caffeine on spontaneous abortion (SAB) has resulted in a large but inconclusive literature [3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26] After considering this literature, the American College of Obstetricians and Gynecologists published a committee opinion in 2010 stating the current evidence did not suggest that consuming less than 200 mg per day of caffeine during pregnancy increased the risk of SAB, but that the evidence for higher doses of caffeine was still unclear [27]. The authors evaluate the association of a prescription diet drug (Letigen) containing ephedrine (20 mg) and caffeine (200 mg) with spontaneous abortion (SAB) in the Danish National Birth Cohort

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