Key result
In utero exposure to cardiovascular agents during pregnancy resulted in minor or major congenital malformations in 6.0% of fetuses and newborns.
Why the study?
What is the rate of congenital malformations in neonates exposed in utero to cardiovascular agents?
Observational (n=134)
Yes
What is the rate of congenital malformations in neonates exposed in utero to cardiovascular agents?
The risk of congenital malformations in neonates exposed to cardiovascular agents in utero was 6.0%, suggesting that the risk posed by the maternal cardiac disease generally exceeds the risk of medications.
Emphasizes individualized risk-benefit assessment for cardiac meds in pregnancy; leaves open need for larger prospective studies on specific agents.
OBJECTIVE: The course of pregnancy is associated with a number of changes in the female body. Literature data indicate that 1-3% of pregnant women develop some cardiac disorder. The aim of the study was to assess the prevalence of using cardiovascular agents in pregnancy, the rate of congenital malformations in neonates at in utero exposure to these agents, and the possible association of congenital malformations with the use of these drugs during pregnancy. METHODS AND RESULTS: One arm of the study (one-month study) was performed at four maternity hospitals in Zagreb, Croatia. The other arm of the study (one-year study) was performed at the University Department of Gynaecology and Obstetrics, Genetic Counselling Unit, and Department of Pathology and Histology in Novi Sad, Serbia. Only pregnant women using drugs for cardiovascular disorders during pregnancy were included in the study. Final analysis included data on 134 (32 from Zagreb and 102 from Novi Sad) pregnant women. Following delivery or abortion, the newborns and foetuses were thoroughly examined and followed-up for the occurrence of minor or major malformations. Malformations were found in 8 (6.0%) foetuses and newborns. CONCLUSION: For most cardiac disorders, the risk posed by the disease itself for both the mother and the foetus generally exceeds the postulated risk of medications used to treat the disease. If a pregnant woman requires such therapy, a respective agent with the best safety profile should definitely be prescribed.
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Erić et al. (2009) conducted an observational in Pregnancy with cardiovascular disorders (n=134). Cardiovascular agents was evaluated on Minor or major congenital malformations. In utero exposure to cardiovascular agents during pregnancy resulted in minor or major congenital malformations in 6.0% of fetuses and newborns.
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