What is preterm birth?

Preterm birth timeline

The goal of a healthy pregnancy is to deliver a baby at 40 weeks of pregnancy. Preterm birth is the delivery of a baby between 20 and 37 weeks.1-3

Preterm birth timeline

If you deliver a baby too early—before 37 weeks of pregnancy, or 3 weeks prior to the due date—this is known as preterm birth.1,4 Sometimes preterm births are unexpected or unplanned, though an early delivery may be necessary in some medical situations.1,4

You’re not alone.

In the US, 1 in 10 babies is born prematurely each year.2 That’s nearly 400,000 babies born too early.5

US preterm birth statistics US preterm birth statistics

Preterm birth rates are different for different racial and ethnic groups.6

Racial and ethnic group US preterm birth rates Racial and ethnic group US preterm birth rates

Preterm birth can happen to any pregnant woman.

Moms who’ve already delivered a baby too early (before 37 weeks)—regardless of the number of weeks early they've delivered—are at a higher risk for having another preterm birth.1,4,7

In most cases, healthcare providers don’t really know what causes a woman to experience preterm birth. But they do know that certain factors may make some women more at risk than others.4

Talk with your healthcare provider to make sure you are familiar with the risks associated with preterm birth. See what you can do to help reduce your risk.

Learn about how to support a healthy pregnancy. Read more

Could you be at risk for preterm birth?

Below are risk factors for preterm birth.4 Please check the ones that apply to you and talk to your healthcare provider if you are pregnant or planning to get pregnant in the future.

The below checklist includes common risk factors for preterm birth. Depending on your risk factor(s), Makena® (hydroxyprogesterone caproate injection) may not be right for you.

While there are many causes for preterm birth, the safety and benefits of Makena have been demonstrated only in women who’ve unexpectedly delivered their baby prior to 37 weeks of pregnancy. It’s not meant for use in women with multiple gestations or other risk factors for preterm birth.

You've checked 1 or more of these risk factors.

Now is the time to talk with your healthcare provider.

Start here

Steps you can take to reduce your risk of preterm birth

While there are no guarantees, you can still take steps to help reduce the chances of your baby being born prematurely. It’s important that you speak to your healthcare provider before you get pregnant and during your pregnancy about your risk for preterm birth, especially if you’ve delivered too early (less than 37 weeks) before.

Eat right

Eat right

Eating healthy during pregnancy provides essential nutrients that you and your baby need. Ask your healthcare provider about which foods are good for you and your baby, and which foods you should avoid. You may also be instructed to take prenatal vitamins.4

Maintain a healthy lifestyle

Maintain a healthy lifestyle

Be sure to get enough rest and relaxation during your pregnancy, especially if you are feeling stressed. You may also need to make some lifestyle changes, such as avoiding smoking, alcohol, and drugs. Ask your healthcare provider about support programs that can help you quit.4

Talk to your healthcare provider

Talk to your healthcare provider

If you are at risk for having a preterm birth, talk to your healthcare provider about ways to help you stay pregnant until full term. There are potential treatments that may help give your baby the time needed to develop.

Start the conversation
Kate and her son
See Kate's story

After speaking with her doctor, Kate made a decision to start Makena® (hydroxyprogesterone caproate injection) because she was at risk for another preterm birth. Hear her story.

Kate gave birth to her son, Gabriel, 5 weeks early (35 weeks). When she became pregnant again with a single baby a year later, she learned she was at risk for another preterm birth and discussed Makena with her healthcare provider.

Indication

Makena (hydroxyprogesterone caproate injection) 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. American College of Obstetrics and Gynecology. Preterm (premature) labor and birth. http://www.acog.org/~/media/For%20Patients/faq087.pdf?dmc=1&ts=20130207T1252359850. May 2013. Accessed January 5, 2017. 2. March of Dimes. Long-term health effects of premature birth. http://www.marchofdimes.org/baby/long-term-health-effects-of-premature-birth.aspx. October 2013. Accessed January 5, 2017. 3. Engle WA, Tomashek KM, Wallman C. Late-preterm infants: a population at risk. Pediatrics. 2007;120:1390-1401. 4. March of Dimes. Preterm labor and premature birth. http://www.marchofdimes.org/complications/preterm-labor-and-premature-birth.aspx. March, 2016. Accessed January 5, 2017. 5. March of Dimes. Prematurity research. http://www.marchofdimes.org/research/prematurity-research.aspx. 2017. Accessed March 22, 2017. 6. March of Dimes. 2016 Premature Birth Report Card: United States. http://www.marchofdimes.org/materials/premature-birth-report-card-united-states.pdf. 2016. Accessed January 5, 2017. 7. CDC. National prematurity awareness month. http://www.cdc.gov/features/prematurebirth/. November 7, 2016. Accessed November 29, 2016.

Important Safety Information and Indication
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IMPORTANT SAFETY INFORMATION
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If you are enrolled in the Makena Care Connection or My Adherence Program, please note that our contact information has changed. If you have questions or would like to get in touch, please contact us at 1-800-847-3418, or write to us at info@makenacareconnection.com.