Page modified at: 16/07/2010
Why 9 Months Count
Growth and development in the last part of pregnancy are vital to a baby's health. The earlier a baby is born, the greater the chance that he or she will have health problems.1
The problem of preterm birth
Some premature babies are fine; they are just small. However, preterm birth is the most common cause of health problems in newborns today. Babies born before 37 weeks may not have had enough time to develop, and may be at risk for health problems. Some of these problems can be treated in the hospital's NICU (neonatal intensive care unit) after birth. Others may result in lifelong problems, including developmental issues and learning disabilities.
Preterm birth is on the rise
The rate of preterm birth is on the rise in the United States. According to the March of Dimes, 1 in 8 babies born in the U.S. is born premature2 — which is more than 500,000 babies a year. While many of these births occur in women with known risks, over 50% of the mothers of premature babies have no risk factors.
Percent of live births, 1995-2004
By 2004, 1 in 8 babies (12.5% of live births) was born preterm in the United States, representing 508,356 preterm births.2
It is best to talk with your doctor about whether your health history or any current health issues may put you at risk for giving birth early
What Are the Symptoms of Preterm Labor?
Even if you don't have any known risks, you should contact your doctor or nurse-midwife if you have any of the warning signs of preterm labor, which can include:1
Contractions (your abdomen tightens like a fist) every 10 minutes, or more often
Change in vaginal discharge (leaking fluid or bleeding from your vagina)
Pelvic pressure — the feeling that your baby is pushing down
Low, dull backache
Cramps that feel like your period
Abdominal cramps, with or without diarrhea
You should also not hesitate to share any other concerns you may have with your doctor or nurse-midwife.
Who Is At Risk for Preterm Birth?
Many pregnant women aren't aware of their risks for having a premature baby. Understanding your risks can help you play an active role in your pregnancy and your baby's health. Then, together, you and your doctor or nurse-midwife can work out a plan. Even if you don't have any of these risk factors, you should contact your doctor or nurse-midwife if you show any of the symptoms of preterm labor, such as regular contractions that don't stop, or constant, dull back pain.
Learn more about medical risk factors.
Certain medical conditions during pregnancy may increase the likelihood that a woman will have preterm labor. These conditions include:
- Previous preterm birth — women who've already delivered a baby early (before 37 weeks) in a previous pregnancy. Also, women who've experienced symptoms of preterm labor in a previous pregnancy are at an increased risk.
- Twins or triplets — women who are carrying twins, triplets, or more at an increased risk. the added weight and pressure of increased babies can lead to an early delivery.
- Cervical or uterine abnormalities —cervical or uterine abnormalities can be a result of surgery or detected by a doctor or nurse midwife. These abnormalities can limit space for the baby to grow, interfere with blood supply to the baby, or weaken the cervix.
- Previous miscarriage(s) — a miscarriage is a pregnancy loss before 20 weeks. There are multiple reasons for a woman to experience a miscarriage; one reason is a cervical or uterine abnormality.
- In vitro fertilization (IVF) — the underlying medical conditions that made IVF necessary or being pregnant with twins or triplets as a result of IVF may put women at an increased risk for preterm birth.
Other medical conditions that may increase the likelihood of preterm labor:
- Urinary tract infections, vaginal infections, sexually transmitted infections
- High blood pressure
- Clotting disorders (thrombophilia)
- Bleeding from the vagina
- Certain birth defects in the baby
- Being underweight before pregnancy
- Short time period between pregnancies (less than 6-9 months between birth and the beginning of the next pregnancy)
If you have any of these three risk factors, it's especially important for you to know the symptoms of preterm labor — and what to do if they occur.
- Late or no prenatal care
- Drinking alcohol
- Using illegal drugs
- Exposure to the medication DES
- Domestic violence, including physical, sexual, or emotional abuse
- Lack of social support
- Long working hours with long periods of standing
Researchers have also identified other risk factors. For instance, African-American women, women younger than 17 or older than 35, and poor women are at greater risk than other women. Experts do not fully understand why and how these factors increase a woman's risk for preterm labor or birth.
There is a test to determine your risk
If you are pregnant, fetal fibronectin testing can help predict your risk for preterm delivery. It is a simple, non-invasive test (much like a Pap test) that can be given in your doctor's office.
What Is Fetal Fibronectin (fFN)?
Fetal fibronectin (also known as fFN) is a “glue-like” protein that bonds your developing baby to your uterus. Fetal fibronectin is detectable in vaginal secretions in the very beginning of pregnancy, when this bond is first forming, and then again at the end of pregnancy, when your body is getting ready to deliver your baby.
How does fetal fibronectin work?
fFN is a special protein that literally holds your baby in place in the womb. After the 35th week of pregnancy, it begins to break down naturally, and is detectable. If your body is getting ready to give birth prematurely, fFN may be detected before week 35. Fetal fibronectin is a “glue-like” protein that holds the developing baby in the womb.
How much fetal fibronectin is normal?
From weeks 22 to 35 in your pregnancy, there should be very little fFN detectable.
Normal fetal fibronectin at each week of pregnancy
From weeks 22 to 35 of pregnancy, detection of fFN could be a sign that your body is getting ready to go into labor prematurely.
What other changes might my doctor look for?
fFN can often be detected before other symptoms of preterm labor, such as contractions and changes in cervical length. Doctors may use a combination of signs and symptoms when deciding the best course of action to take in relation to your pregnancy.
What is a Fetal Fibronectin Test?
A fFN test by Hologic is a safe, reliable, non-invasive test (similar to a Pap test) that can help your doctor tell if your body may be getting ready for delivery, even before you feel any of the symptoms.
Preterm birth risk assessment
There are 2 types of assessments that can be made for preterm birth risk: biophysical and biochemical. Biophysical markers include contractions and changes in cervical length that may be precursors of labor. Fetal fibronectin, a biochemical marker, can often be detected before the biophysical markers.
NIH preterm prediction study: Risk factors for preterm birth1
Ask your doctor about a fetal fibronectin test
fFN testing is approved for use in women from weeks 22 to 35 of pregnancy. Your doctor or nurse-midwife can determine whether it will be useful in your situation, so talk with your doctor or nurse-midwife about the test, your risk for premature birth, and if getting the test makes sense for you.
Fetal Fibronectin Specimen Collection
The fetal fibronectin specimen must be collected during a speculum examination before any other vaginal exam is performed. Lubricating gels will interfere with the test results.
For accurate patient results, please ensure that you follow these specimen collection instructions.
- The specimen should be collected prior to a digital cervical exam, collection of culture specimens, or vaginal probe ultrasound exams.
- Do not contaminate the swab or specimen with lubricants, soaps, disinfectants, or creams.
- Do not collect specimen if patients have had sexual intercourse within 24 hours prior to sampling; moderate or gross vaginal bleeding; advanced cervical dilation (3 cm or greater); rupture of membranes; gestational age <22 weeks or >35 weeks; or suspected or known placental abruption or placenta previa.
Should You Get A Fetal Fibronectin Test?
Getting a fFN test is a way for you to be actively involved in your pregnancy and your baby's health. Women with risk factors or symptoms of preterm labor should get tested to help provide their doctors with important information. There are also other possible reasons why you and your doctor may decide that the test is right for you, so it is important to discuss your situation with your doctor or nurse-midwife.
If You Have Significant Risk Factors
Testing for fetal fibronectin is a way to help you and your doctor know what to expect. You may be at risk if you have one of the following risk factors:
Symptoms of preterm labor
- Symptoms of preterm laborThese include contractions every 10 minutes or more often, change in vaginal discharge, pelvic pressure, backache, menstrual-like cramps, or abdominal cramps with or without diarrhea.1
- A prior preterm birth
If you've already delivered a baby early (before 37 weeks), or if you've experienced preterm labor in a prior pregnancy, you have an increased risk of delivering early again
- Cervical abnormalities
If you have cervical abnormalities as a result of surgery or as detected by your doctor during ultrasound, you may be at increased risk of delivering your baby early.
- Twins or triplets
If you are carrying twins or triplets, the added weight and pressure of multiple babies can lead to an early delivery.
Know what to expect
Most women who get tested, will have a negative test result, which can give them great "peace of mind" — a negative test result means you can be 99.2% assured that you won't go into labor in the next two weeks.1 On the other hand, if you get a positive test result, that does not always mean your baby will be born preterm.
Your doctor or nurse-midwife can help
If you think you could be at risk of having an early birth, ask your doctor or nurse-midwife about fFN. The more you know now, the better you will be able to care for your baby throughout your pregnancy.
Supported by research
In the NIH Preterm Prediction Study of 2929 pregnant women, fFN testing predicted almost two-thirds of the spontaneous preterm births at less than 28 weeks.2 In a study of symptomatic women, 99.2% of women with negative fetal fibronectin test results did not deliver in the next 14 days.3
What the Experts Say About Fetal Fibronectin
You trust your doctor or nurse-midwife to do all he or she can to help bring your baby as close to term as possible. Hear what the experts are saying about fFN.
Fetal Fibronectin in Practice
Clinicians from throughout the country are discovering the benefits of fetal fibronectin. Here's what a few of them had to say about the test's usefulness, and how it compares to other methods of assessing preterm labor risk.
Kathryn Shaw, MD, is a perinatologist at White Memorial Medical Center in Los Angeles. She finds fFN testing to be "far superior" to other methods of assessing the risk of preterm delivery. This test has been very useful in identifying patients who are not at risk for preterm birth, and thus allows for less intervention and less disruption of those patients' lives. It also allows for more timely intervention, based on a positive fFN result, when clinical symptoms are minimal.
Thomas A. Raskauskas, MD, of the North Shore Medical Center in Salem, Massachusetts, finds fFN testing to be "the best method to date" for assessing preterm delivery risk. He tests asymptomatic women with a history of preterm birth or other risk factors for PTB. A woman who had two normal term deliveries presented at 31 weeks with contractions. Her initial fFN test was negative, and a repeat test one week later also was negative. The patient, who was the breadwinner of her family, returned to work one week after the initial evaluation, and is still pregnant at 37 weeks. Because of the reassurance provided by the negative results, she was able to retain her full salary, without losing her maternity benefits.
John M. Thorp, Jr, MD, is a perinatologist and professor of obstetrics and gynecology at the University of North Carolina School of Medicine. The majority of his patients are high risk. Dr. Thorp relies on the high negative predictive value of a fFN test to avoid unnecessary treatment of preterm labor symptoms. He finds the test to be "superior to clinical judgment. Dr. Thorp recalls a patient who was reluctant to become pregnant again due to preterm uterine activity in a previous pregnancy, and who did not want to be "sentenced" to bed rest again. Using the negative predictive value, we were able to avoid unnecessary treatments for her uterine activity, and she was able not only to work until term, but also to care for her child.
Daniel Eller, MD, uses fFN testing in his urban, maternal-fetal medicine practice in Atlanta, Georgia. He tests hospitalized patients with shortened cervices or symptoms of preterm labor and outpatients with shortened cervices or other risk factors for PTD. fFN helps him determine which patients need to be hospitalized and for how long. He says that a negative test result allows him to be less aggressive with tocolytics and hospitalization than he otherwise would be. Dr. Eller's patients reap the benefits when they avoid weeks or even months of hospitalization by virtue of testing negative. Of one patient in particular, he says: I know she appreciated being home with her family, and she said the negative results gave her a sense of security. In addition, the cost of her maternity care was significantly reduced."
Reliable Results With Fetal Fibronectin Testing
Among the existing risk factors for preterm birth, fFN is the most powerful independent predictor of preterm birth <32 weeks, even more so than prior preterm birth or cervical length.1
For women with a negative fetal fibronectin test result
Approximately 99.2% of women with symptoms of preterm labor who have a negative test result will not deliver within the next two weeks.2 Less than 1% of women will deliver before 28 weeks if they have a negative fetal fibronectin test result at 22 to 24 weeks.3
Negative Test Results
In a woman at risk with symptoms of preterm labor, a test result that is negative provides 99.2% assurance that she will not deliver in the next two weeks.1 This helps make it possible to:
- Alleviate patient uncertainty
- Avoid unnecessary hospitalization, testing, and extended maternity leave
- Reduce or eliminate unnecessary interventions
- Provide important education regarding symptoms
- Reassure patients that they have less than a 1% chance of delivery within the next 14 days1
- Reduce or eliminate costs associated with hospital admissions and transportation
- A physician may wish to monitor the patient's fFN test results at her office visits. fFN tests, can be given as often as biweekly, from weeks 22 to 35, in order to monitor the presence of fetal fibronectin.
For women with a positive fetal fibronectin test result
Over 40% of women with symptoms of preterm labor who have a positive test result will deliver prematurely (before 37 weeks of gestation).4 A woman who tests positive at 22 to 24 weeks is nearly 60 times more likely to deliver within the next 4 weeks, compared with a woman with a negative test result.5
Positive Test Results
A small percentage of women will get a positive test result, which can help identify which of your patients may require extra attention. Management plans may include closer surveillance, reduced daily activity, and treatment options.
Positive Test Results in Women at Risk - With Symptoms
For women with symptoms of preterm labor, a positive test result may warrant consideration of increased patient surveillance and management. A positive test result can also provide the patient with confidence in the need for increased surveillance and management options.
Positive Test Results in Women at Risk - With No Symptoms
Women at risk with no symptoms of preterm labor were nearly 60 times more likely to deliver within 4 weeks after a positive test result at 24 weeks than women with a negative test result.1
Patient management following a positive test result
Following a positive test result, care decisions can be considered, such as increased intensity of prenatal observation, evaluation of other risk factors, increased patient education, and possible earlier intervention. Patients may also benefit from the availability of increased surveillance, management options, and preparation for optimal neonatal care.
In the NIH Preterm Prediction Study, fFN testing detected nearly two-thirds of the preterm births that occured prior to 28 weeks.6
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