Prepidil and Pregnancy
Although Prepidil (dinoprostone vaginal gel) is a pregnancy Category C medicine, it is unlikely to cause complications in the development of a fetus. This is because the drug should only be used when it is time to deliver the baby. However, this medication may have a potential risk for fetal harm if abnormally strong and frequent uterine contractions occur.
Can Pregnant Women Receive Prepidil?Prepidil® (dinoprostone vaginal gel) is a prescription medication used to prepare the cervix for induction of labor in certain pregnant women. It is considered a pregnancy Category C medication based on the results of animal studies.
What Is Pregnancy Category C?The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but do appear to cause harm to the fetus in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Prepidil is a synthetic version of prostaglandin E2, a hormone that is found naturally in the body. Prostaglandin E2 is important for labor and delivery to occur.
When given to pregnant rats and rabbits, prostaglandin E2 increased the risk for skeletal defects in the fetuses. However, when used as directed, Prepidil is given after the fetal organs have developed. Therefore, the medication is not likely to cause birth defects with normal use.
In addition, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
However, there is a potential for fetal harm if abnormally strong and frequent uterine contractions occur from Prepidil use. Your healthcare provider will monitor your contractions, and the health of your fetus, when you receive this medication.