Background Prolonged use of magnesium sulfate is a common tocolytic treatment often used to stop preterm delivery. However, in 2013, the U.S. Food and Drug Administration (FDA) issued a safety warning that recommended not using magnesium sulfate injection for more than 5-7 days to stop preterm delivery due to a low calcium level and bone problems observed in infants. Given the FDA warning was based on case reports, whether the prolonged magnesium sulfate use among pregnant women in Taiwan is associated with an increased risk of subsequent infant fractures remains unknown. Purpose The purpose of this study is to determine whether the prolonged magnesium sulfate use for tocolysis increases the risk of subsequent fractures among neonates and infants in Taiwan. Method We will identify a cohort of pregnant women (12 to 55 years of age) during January 1, 2002 to December 31, 2012 by using the Full Population Data of the Health and Welfare Database managed by the Health and Welfare Data Science Center of the Department of Statistics under the Ministry of Health and Welfare in Taiwan. We will further use the birth-certificate registry database to establish mother-child pairs between pregnant women and their infants. Pregnant women who received prolonged magnesium sulfate for more than seven days will be defined as the prolonged magnesium sulfate users. We will use the logistic-regression model to estimate odds ratio, Poisson regression model to measure the incidence rate ratio (IRR), and the Cox-proportional hazard regression model to compare time to the diagnosis of infant fractures between 1) the prolonged users versus nonusers, 2) the prolonged users versus regular users (use magnesium sulfate for less than seven days), 3) the prolonged users in the first and second trimesters versus prolonged users in the third trimester, and 4) the prolonged users versus users with other tocolytics than magnesium sulfate. Propensity score matching will be used to balance the selected confounders between groups. Anticipated outcomes We expect that infants born from pregnant women receiving prolonged magnesium sulfate will have a higher risk of fractures compared with infants born from pregnant women without magnesium sulfate use. The results will inform obstetricians, gynecologists, and pharmacists the potential risk of the prolonged magnesium sulfate use for tocolysis, and will ultimately improve tocolytic treatment outcomes among pregnant women and their babies in Taiwan.
|Effective start/end date||8/1/17 → 7/31/18|
- Magnesium sulfate
- Infant fractures