Could You Be at Risk for Preterm Birth?

Risk factors: what you need to know

In most cases, healthcare providers don’t fully understand what causes a spontaneous (unplanned) preterm birth.¹ But they do know certain risk factors may make some women more likely to have a preterm delivery than others (see chart). For instance, having already had a preterm delivery is a significant risk factor for another preterm birth.²

Talk with your healthcare provider to make sure you are familiar with the warning signs of preterm birth. Find out what you can do to help reduce your risk.

Risk factors for preterm delivery

Just because you have one or more of these risk factors doesn’t necessarily mean you will have a premature baby. But having had a preterm delivery before is a significant risk factor for another preterm birth, so it is important that you are aware of any warning signs.

While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.

Makena^® is a prescription hormone medicine (progestin) used to lower the risk of preterm birth in women who are pregnant with one baby and who have delivered one baby too early (preterm) in the past. Makena was shown to work based on a lower number of women who delivered babies at less than 37 weeks of pregnancy. There are no studies showing Makena reduces the number of babies who have serious problems shortly after birth or who die. It is not known whether Makena is safe and effective in women who have other risk factors for preterm birth.

Important safety information for Makena (hydroxyprogesterone caproate injection)

Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to your current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure.

Before you receive Makena, tell your healthcare provider if you have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.

In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in your urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).

Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of your skin and the whites of your eyes. Call your healthcare provider right away if you think you have symptoms of a blood clot (leg swelling, redness in your leg, a spot on your leg that is warm to touch, or leg pain that worsens when you bend your foot) or symptoms of an allergic reaction (hives, itching, or swelling of the face). The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.

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.

Please see full prescribing information for Makena.

References: 1. ACOG Education Pamphlet AP087. The American College of Obstetricians and Gynecologists. Available at: www.acog.org. Accessed October 20, 2009. 2. March of Dimes Foundation. March of Dimes^®. Available at: www.marchofdimes.com. Accessed October 20, 2009. 3. Spong CY. Prediction and prevention of recurrent spontaneous preterm birth. Obstet Gynecol. 2007;110:405-415.