If your Doctor or Midwife has told you that you might need help getting your labor started, it’s important to know about the induction process and your options.
Induction is the use of medication or other methods to help get labor started. Induction is typically recommended by your Doctor or Midwife if you are at or past your due date and there are no signs of labor.
The goal of labor induction is to have a vaginal birth, which is following the same process your body would typically go through.3
Labor induction is actually a 2-step process. The first step is called pre-labor and involves your cervix. In order for delivery to happen, your cervix needs to open (dilate), soften and thin out. The medical term for this process is cervical ripening.
If your cervix does not soften, thin and dilate on its own, CERVIDIL can help prepare your cervix for labor.
Once your cervix is ready, contractions should begin. If contractions don’t happen naturally, your Doctor or Midwife will recommend Pitocin® (oxytocin).
In clinical trials, fever, nausea, vomiting,
diarrhea and abdominal pain were
noted in less than 1 in 100 women who
were given CERVIDIL.
CERVIDIL works directly on the
cervix. It makes the cervix soft,
thin and opened (dilated). This is
called cervical ripening.
You may be able to move
around 2 hours after
CERVIDIL is inserted.
CERVIDIL is easily removable using
the retrieval string. The medication
is out of your system minutes after
the insert is removed.
CERVIDIL® (dinoprostone, 10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor.
For the first two (2) hours following insertion, you should remain lying down. If you sit up or walk after the first two hours, you should be careful to ensure the insert remains in place. While CERVIDIL is inserted, your doctor will carefully monitor your progress and your baby’s well-being and will determine when the insert should be removed.
IMPORTANT SAFETY INFORMATION ABOUT CERVIDIL
CERVIDIL should only be inserted by a trained healthcare professional in a hospital setting appropriate for childbirth.
Who should NOT be given CERVIDIL?
You should NOT be given CERVIDIL if you have:
You should also NOT be given CERVIDIL if your doctor has determined that:
What are the most serious risks associated with the use of CERVIDIL?
The induction of labor has been associated with an increased risk of a disorder of abnormal clotting of the blood that results in excessive bleeding immediately after birth (“disseminated intravascular coagulation” or DIC). The risk is higher in women over age 30, those with complications during pregnancy, and those whose pregnancy has lasted longer than 40 weeks.
In rare cases, the use of CERVIDIL has been associated with an increased risk of a life-threatening event to the mother called “amniotic fluid embolism.” The cause of amniotic fluid embolism is not well understood but it is believed that some amniotic fluid or other substances can get into your bloodstream and start a severe reaction that can cause heart and lung collapse.
What should I discuss with my doctor before labor induction begins or CERVIDIL is given?
As you would throughout your pregnancy, be sure to tell your doctor about all prescription or over-the-counter medications you are taking. Before CERVIDIL is given, be sure you have told your doctor about all your current and past medical conditions, including:
What are the most common side effects of CERVIDIL?
The most common side effects associated with the administration of CERVIDIL are contractions occurring at a rate faster than normal (tachysystole) and signs that the baby is exhausted or in distress (uterine hyperstimulation). In clinical trials, these effects occurred alone or together in less than 1 in 20 women who were given CERVIDIL.
In clinical trials, fever, nausea, vomiting, diarrhea and abdominal pain were noted in less than 1 in 100 women who were given CERVIDIL.
This is not a complete list of possible side effects.
If you experience an adverse event please discuss it with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.
People depicted in images are models. Images used for illustrative purposes.
Please see full Prescribing Information
References: 1. CERVIDIL [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc. 2. FDA Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. Accessed August 17, 2015. 3. The American College of Obstetricians and Gynecologists. Frequently Asked Questions: Labor, Delivery, and Postpartum Care. http://www.acog.org/Patients/FAQs/Labor-Induction. Published 2017. Accessed March 5, 2018.
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All drugs must be proven safe and effective to FDA’s regulations before companies can market them. If the FDA grants approval to a drug, it means they have determined that the benefits of the product outweigh the risks for the intended use.