Cervidil and Pregnancy
Only pregnant women who are close to delivery should receive Cervidil (dinoprostone vaginal insert), as this drug is approved to help prepare the cervix for childbirth. This product is classified as a pregnancy Category C medicine, as it caused skeletal defects during animal studies. Also, this drug may cause strong and frequent contractions, which may cause fetal distress in some cases.
Can Pregnant Women Receive Cervidil?Cervidil® (dinoprostone vaginal insert) is a prescription medication used to promote cervical ripening (softening of the cervix) in preparation for labor and delivery. It is only approved for use in pregnant women. However, 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 fetal harm 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.
Cervidil 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, Cervidil 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.
It should be noted that Cervidil can cause abnormally strong and frequent uterine contractions, which can lead to fetal harm. It has also been associated with fetal distress (when the fetus is not doing well). You will be monitored closely for these side effects if you are given Cervidil, and the vaginal insert will be removed if problems occur. In clinical studies, most problems reversed, usually within 2 to 13 minutes, after the vaginal insert was removed.