Treatments, Tests and Technologies to Delay or Prevent Preterm Birth

IS YOUR PHYSICIAN COMMITTED TO PRETERM BIRTH PREVENTION?

Many of the most significant changes in maternity-related care have been driven by women (for example, natural childbirth, dads in the delivery room, changing the "drive-through delivery" policy). Fortunately, a growing number of obstetrical specialists (perinatologists) do not accept that a premature baby is "God's will" or just "nature taking its course". These physicians are proponents of early identification of women at risk, bedrest, tocolytic therapy, cervical cerclage, psychosocial support, and perhaps most importantly, patient education. They empower women with information and involve them in the plan of care. If your physician is not a strong advocate of patient involvement and preterm birth prevention efforts - consider changing doctors. It's your body, your pregnancy, your baby.

HOME UTERINE ACTIVITY MONITORING (HUAM)

Many women at risk for preterm delivery have benefited from home uterine activity monitoring (HUAM) and preterm labor management services. HUAM is an external monitoring device that a pregnant woman wears on her abdomen twice a day for one hour. The HUAM records contractions that may be too faint for the woman to detect on her own. The data is then transmitted over the phone to a nurse who then analyzes the information. If there are excessive contractions, the physician is then notified.

When preterm labor is detected in time, treatment often involves limited activity or bedrest, and medications called "tocolytics".

TOCOLYTICS

Tocolytics are drugs that are used to suppress preterm labor. These might include prescribed drugs with the names Ritodrine, Terbutaline, Indomethacin, or Magnesium Sulphate. Each of these drugs works in a different way, but the goal is to minimize the strength and number of contractions which may cause the cervix to dilate. Drugs may be given either in pill form, I.V., or subcutaneously (under the skin). Your doctor may prescribe your medication to be administered by a 'pump', which delivers a small amount of the drug automatically through a device similar to that used by insulin dependent diabetics. The small amount delivered subcutaneously reduces side effects such as shaking and feeling jittery.

You can discuss with your doctor the tocolytic therapy regimen that is best for you.

SALIVARY ESTRIOL (SalEst)

A new test just given FDA approval, salivary estriol assists physicians in identifying those women at risk for spontaneous preterm labor and delivery. The SalEst system is approved for use in women between their 22nd and 36th week of pregnancy.

The SalEst system measures levels of the hormone, estriol, in saliva. Clinical research demonstrates that there is a surge in salivary estriol several weeks prior to the onset of spontaneous preterm labor. Sample collection, based on a sample of saliva, is an easy process which can be done in the physician's office or patient's home. A tube is sent to a lab and results are returned usually within 48 hours.

The test has only recently received FDA approval so your insurance company may not yet know about it. The test costs less than $100. If your physician prescribes the test and your health plan doesn’t yet cover it, contact the company directly. The toll-free number for Biex is (888) 404-2439 (1 800 404-BIEX).

FETAL FIBRONECTIN (fFN)

Fetal Fibronectin (fFn) is a test that has been FDA approved since 1995. It is used by healthcare providers worldwide to identify women at risk for premature delivery. Fetal fibronectin is a protein, which is present at the interface between mother and fetus. When this interface is disrupted, fetal fibronectin is detected in vaginal secretions. A positive test acts as an early warning and helps identify women at risk for preterm delivery, while a negative test reassures the woman that it is highly unlikely delivery will occur in the next 7-14 days. A negative fetal fibronectin test will allow many women to be spared unnecessary treatment as a result of prolonged bedrest and limited mobility.

A new Rapid Fetal Fibronectin test makes it possible to have results available to the patient in less than one hour. It involves a simple cervical swab taken in the doctor’s office between 22 and 34 weeks gestation. The office send your sample to a lab near your home or hospital and your test results are usually available within one hour. Most insurance companies know about this test and are reimbursing for it. Ask your healthcare provider how you can be tested for fetal fibronectin.

For more information or to receive a patient brochure, contact Adeza Biomedical at 1-888-PRETERM or visit their website at http://www.adeza.com.

BEDREST

A simple and commonly prescribed therapy used for preterm labor contractions is bedrest. The doctor may prescribe varying levels of bedrest with limited activity or complete bedrest in the Trendelenburg position (head down, feet up). Bedrest is often recommended for women with multiple gestations (twins or more), preeclampsia (high blood pressure), and those diagnosed with incompetent cervix.

It is important for you to discuss with your doctor what range of activity you may participate in when bedrest is prescribed. Daily activities such as meal preparation, bathing, car pooling children to school, housework, and regular job duties need to be evaluated.

CERVICAL CERCLAGE

Cervical Cerclage has become the standard treatment for incompetent cervix and involves the sewing of the cervical opening to prevent the cervix from opening. The most common procedures are Schrodkar, McDonald, and Transabdominal cervicoisthmus.

Many women who have had recurrent mid trimester pregnancy losses may be candidates for this procedure. Congenital factors, such as exposure to DES, cervical trauma, or hormonal influences, can be factors in incompetent cervix diagnosis. Early elective cerclage placement has a significantly higher success rate than those performed after effacement and dilation have occurred.

Does Home Uterine Activity Monitoring Have Any Value To Women At Risk For Preterm Delivery?

WHAT IS A HOME UTERINE ACTIVITY MONITOR? (HUAM)

HUAM is a system of monitoring women for contractions which may indicate the onset of preterm labor. Three monitors have been approved by the FDA for earlier detection of preterm labor in women at high risk for preterm delivery.

High risk mothers monitor themselves at home with the device worn around the abdomen for one hour, twice a day. Uterine activity, including contractions and irritability, is recorded then transmitted over phone lines to a nurse. If an excessive number of contractions are occurring, the nurse notifies the physician. An examination may then be needed to determine if labor has begun. Early treatment of preterm labor provides an opportunity for prolonging the pregnancy thereby allowing the baby to gain more weight, increase lung development, and prepare for birth.

WHY WAS IT APPROVED AS A MEANS FOR HELPING DETECT PRETERM LABOR?

Preterm birth is the leading cause of infant mortality and morbidity and is therefore considered the foremost problem in obstetrical medicine. In spite of progress in neonatal intensive care in saving the lives of smaller and earlier babies, survival does not guarantee restored health of these little ones.

The ideal solution to preterm birth is to provide more time for the baby to develop in the womb. The majority of preterm births occur because preterm labor is not detected in time to avoid imminent delivery. Many women cannot feel preterm labor contractions until it is too late for treatment. HUAM helps physicians in their efforts to manage the labor process so the pregnancy can continue.

WHAT HAS THE RESEARCH SHOWN ABOUT THE VALUE OF HUAM?

HUAM has been in use for over a decade and has been extensively studied in large populations of women at high risk for preterm delivery. It's safety has been well documented and is not an area of dispute. HUAM has been consistently shown to be a valuable tool in the earlier detection of preterm labor. This value is based on the fact that high-risk women who received this level of care gave birth to babies born at higher birth weights and required less time in neonatal intensive care.

THE AMERICAN COLLEGE OF OBSTETRICIAN AND GYNECOLOGISTS (ACOG) HAS SAID THAT HUAM IS "INVESTIGATIONAL". WHY DO THEY TAKE THAT POSITION IF HUAM HAS VALUE?

The ACOG committee that evaluated HUAM based their decisions on the criteria that HUAM does not "prevent preterm birth". That is true, in the same way that a mammogram does not prevent breast cancer. HUAM is a devise used to aid in diagnosis, not a treatment to prevent preterm labor or preterm birth.

MY PHYSICIAN SAYS I AM AT RISK FOR PRETERM DELIVERY BUT WILL NOT PRESCRIBE A HUAM. WHAT SHOULD I DO?

If you are confident that you can feel the contractions for preterm labor, you can ask for instructions in self-palpation (manually checking the uterus for contractions). This method involves checking for pressure and keeping a record of abdominal tightening. Your doctor will tell you when to report an increase in contractions.

If you doubt that you can feel preterm labor contractions, you may want to ask your doctor to try HUAM for a short time and compare the number of contractions you feel with the number detected by the monitor.

Your physician may or may not be specialized in high risk obstetrical medicine. If you are at risk for preterm delivery, you need expert care. Seek a second opinion from a qualified physician if you ever have concerns that are not being addressed.

MY MEDICAL INSURANCE CARRIER SAYS THAT HUAM IS NOT COVERED. IS THERE ANYTHING I CAN DO ABOUT IT?

Don't take denial of benefits lying down. Call your case manager, insurance representative or benefits manager in your company's human resource department. Have your doctor write a letter of explanation. Find other resources to pay for the care or call the provider and ask how you can get the care that you need. Many providers have insurance advocates who will do the work for you.

References:

Sidelines National Support Network

Treatments, Tests and Technologies to Delay or Prevent Preterm Birth

http://www.obgyn.net/_multibirths/articles/prevent_ptl.htm

2001