Drugs Home > Dinoprostone and Pregnancy

Women who are pregnant may receive dinoprostone for several reasons, such as to cause an abortion or to relax the cervix in preparation for delivery. Although this drug is approved for pregnant women, dinoprostone is classified as a pregnancy Category C medication based on the birth defects and other problems it caused during animal studies.

Can Pregnant Women Receive Dinoprostone?

Dinoprostone (Cervidil®, Prepidil®, Prostin E2®) is a prescription medicine used in lower doses to prepare the cervix for labor and delivery in pregnant women. Higher doses are used to terminate a pregnancy. Based on the results of animal studies, this drug may cause fetal harm.

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 used during pregnancy. Dinoprostone is classified as a pregnancy Category C drug.
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused 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.
Dinoprostone is a synthetic version of prostaglandin E2, a hormone that is naturally found in the body. Prostaglandin E2 is important for labor and delivery to occur. It causes the cervix to thin and soften so the unborn baby can pass through during delivery. It also causes uterine contractions.
When given to pregnant rats and rabbits, prostaglandin E2 increased the risk for skeletal birth defects. However, dinoprostone is usually given after organs have developed, and is therefore unlikely 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, dinoprostone causes contractions of the uterus. If these contractions become too strong or frequent, it could cause fetal harm. In addition, this medication has been associated with an abnormal fetal heartbeat and fetal distress (when the fetus is not doing well). Therefore, your healthcare provider will monitor your contractions and the health of your fetus if you receive this medication to prepare for labor and delivery.
Because of the potential for fetal harm, the manufacturer of dinoprostone vaginal suppository recommends that other procedures be used to complete an abortion in the event that it is not successfully completed with dinoprostone. An incomplete abortion could also harm a woman by causing infection and dangerous bleeding.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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