What is Dinoprostone used for in pregnancy?

Cervidil is a brand drug used to dilate the cervix and induce pregnancies in women who are at the end of their pregnancy term or near the end. It comes in the form of a vaginal insert and contains prostaglandin.

Prostaglandin is a hormone that is produced in several parts of the body. Its function depends on which part of the body it’s made.

Prostaglandin is responsible for controlling the menstrual cycle, ovulation, and inducing labor in the female reproductive system. A synthetic version of prostaglandin is used in Cervidil, to relax the muscles of the cervix and induce labor.

Cervidil is also known as dinoprostone, which is its generic name. It’s the only FDA approved vaginal insert for relaxing the cervix during labor.

For delivery to occur, your cervix needs to open up, soften, and thin out. This process is called cervical ripening, and Cervidil can be used to trigger it if your cervix doesn’t do it on its own.

Cervidil is used as the first step in inducing a pregnancy. Its role is to soften and relax the cervix and prepare it for a baby to pass through. Cervidil serves any or a combination of these two main functions:

Inducing contractions
Softening the cervix

You should know that Cervidil doesn’t work the same way for all women. In some women, it succeeds at only relaxing the cervix while it induces contractions in other women. The insert is removed when you no longer need it or after 24 hours.

A Cervidil insert might also be removed if:

Your water breaks after it’s put in
It doesn’t appear to be effective and your doctor wants to try a different medication to help your cervix relax
You’ve started labor
Your contractions are too strong
Your baby appears to be in distress

The effects of Cervidil stop almost immediately after the insert is taken out.

Cervidil is shaped like a slim tampon with a long tape attached. It must not be used without the tape, like with the string on a tampon, the tape on a Cervidil insert is needed to be able to pull it out later.

It is inserted through your vagina. It’s put in until contractions begin or for a maximum of twelve hours. Each insert of Cervidil contains 10 milligrams (mg) of dinoprostone.

Cervidil can only be prescribed by a doctor and administered by a medical professional. Every hour the insert gradually releases 0.3 mg of dinoprostone into the vagina.

The maximum recommended period of usage is 24 hours. You are required to lay on your back as the insert is being put in, and asked to remain in that position for at least 30 minutes, after which you are allowed to move around.

After Cervidil is inserted, the vagina is carefully monitored for any changes in the cervix. If contractions begin, the frequency and strength of the contractions are monitored. The baby’s health is also closely monitored to prevent adverse reactions.

Cervidil is only administered to women having a natural birth. However, it won’t be given to women who are having more than one baby.

Other situations in which Cervidil is not administered include:

If you are already in labor
If your vagina can’t tolerate vaginal inserts. For instance, if you have a disease like genital herpes
If you have unusually strong contractions
If your baby isn’t in the normal position it should be (which is with the head faced towards your pelvis)
If you’ve had a cervical surgery
If a problem with your baby is detected
If your pelvis is too small, or the head of your baby is too large for a natural birth

Cervidil is relatively safe and few people report having any side effects on it. When side effects do occur, they are minor and include nausea, vomiting, headaches, or back pain.

If you have an allergic reaction to dinoprostone, Cervidil will not be given. If it has already been given, it will be removed if your doctor notices any signs of swelling, difficulty breathing, or development of hives.

Before Cervidil is administered, the doctor will ask a couple of questions to ensure you don’t experience any adverse reactions to the drug. The questions usually include details of your family history, other medications you are currently on, and details of your medical history.

Administering Cervidil is strongly discouraged if the person in labor has:

Anemia: Cervidil is prescribed with caution to women who are anemic. This is because, when used to induce contractions, it might result in blood loss. In some cases, a blood transfusion might be needed.
Asthma: For people with asthma, Cervidil might cause the blood vessels in your lungs and your lung passages to narrow as it induces contractions in your cervix. This might cause an asthma attack.
A history of cesarean sections or uterine surgery: In women who have had a cesarean section or uterine surgery, prolonged contraction of the uterus might be unsafe for the fetus and damaging to the uterine. Administering Cervidil might cause a potential risk for uterine ruptures. If it’s used, the progress of your dilation will be carefully monitored. If there are any indications of uterine or fetal distress, the insert will be immediately removed.
Other medication: You won’t be given Cervidil if you’ve been given or are going to be given any other medication that can induce labor like oxytocin for example.

In rare cases, the use of medication that contains dinoprostone like Cervidil has been linked to the risk of developing amniotic fluid embolism. This condition causes amniotic fluid to enter your bloodstream resulting in a severe reaction that could lead to heart or lung failure.

Women who are above the age of 30, women who experience any complications with their pregnancy, and women who have carried their babies for more than 40 weeks, have an increased risk of developing postpartum disseminated intravascular coagulation when Cervidil is used.

Disseminated intravascular coagulation is a condition where blood clots form easily and could block blood vessels, which can result in organ damage. However, it’s important to know that adverse reactions to the drug are rare.

Since dinoprostone is used when needed in a clinical setting, it does not have a daily dosing schedule.

Included as part of the PRECAUTIONS section.

PRECAUTIONS

For Hospital Use Only

CERVIDIL should be administered in a hospital setting with an obstetrical care facility.

Disseminated Intravascular Coagulation

CERVIDIL should be used with caution in women at high risk of postpartum disseminated intravascular coagulation (DIC). Physiologic or pharmacologic induction of labor, including the use of CERVIDIL, is associated with an increased risk of DIC during the postpartum period. Women aged 30 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have an increased risk of DIC during the postpartum period. As soon as possible, assess for an evolving fibrinolysis in the immediate post-partum period. Therapy consisting of prompt removal of the source of procoagulant material, replacement of depleted clotting factors and, in some cases, anti-coagulation with heparin should be instituted promptly.

Amniotic Fluid Embolism Syndrome

The use of dinoprostone-containing products, including CERVIDIL, can result in inadvertent disruption and subsequent embolization of antigenic tissue causing the development of Amniotic Fluid Embolism Syndrome, a rare and often fatal obstetric condition.

Carefully monitor patients for clinical signs of Amniotic Fluid Embolism Syndrome including hypotension, hypoxemia and respiratory failure, DIC, coma or seizures and provide supportive care as needed.

Uterine Tachysystole And Uterine Hypersystole/Hypertonicity

The use of CERVIDIL may cause uterine tachysystole with or without fetal heart rate changes (see Table 1). While using CERVIDIL, carefully monitor uterine activity, fetal status and the progression of cervical dilatation and effacement. Remove CERVIDIL with any evidence of uterine tachysystole, uterine hypersystole/hypertonicity, fetal distress, or if labor commences. CERVIDIL is contraindicated when prolonged contraction of the uterus is detrimental to fetal safety or uterine integrity, such as previous cesarean section or major uterine surgery, because of the risk of uterine rupture and obstetrical complications (e.g., need for hysterectomy and the occurrence of fetal or neonatal death). Prostaglandins, including CERVIDIL, may potentiate the effect of oxytocin [see DRUG INTERACTIONS]. Remove CERVIDIL at least 30 minutes before administration of an oxytocic agent is initiated and continue to carefully monitor uterine activity. Remove CERVIDIL prior to amniotomy or following rupture of membranes because the higher vaginal pH that occurs with rupture of membranes may result in higher release rate of dinoprostone.

Glaucoma

Prostaglandins, including CERVIDIL, can lead to raised intraocular pressure and constriction of pupils. Consider non-prostaglandin cervical ripening procedures in patients with Glaucoma.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term carcinogenicity and fertility studies have not been conducted with dinoprostone. No evidence of mutagenicity has been observed with dinoprostone in the Unscheduled DNA Synthesis Assay, the Micronucleus Test, or the bacteria reverse mutation (Ames) test.

Use In Specific Populations

Pregnancy

Risk Summary

CERVIDIL is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor. Fetal, neonatal, and maternal risks are discussed throughout the labeling. Limited available data with CERVIDIL use in pregnant women do not show a clear association with adverse developmental outcomes. Relevant animal reproduction data with dinoprostone is not available.

Data

Human Data

In a report of a 3-year pediatric follow-up study, there were no deleterious effects noted on physical examination or psychomotor evaluation of 51 infants born following maternal treatment with CERVIDIL.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

When CERVIDIL was removed for fetal distress, there was a return to normal rhythm and there were no neonatal sequelae. Remove CERVIDIL in the event of persistent tachysystole with or without fetal heart rate changes, and follow established institutional protocols in management of patients.

Lactation

Risk Summary

Concomitant administration of CERVIDIL is not indicated in breastfeeding women. There is no information on the effects of maternal CERVIDIL administration on the breastfed child. Insufficient information is available on the effects of maternal CERVIDIL administration on milk production.