Preterm Labor Management
Frequently Asked Questions

For the Patient:

1. Who is at risk for preterm birth?
2. What is considered preterm?
3. What is labor?
4. What is preterm labor? What is the cause of preterm labor?
5. What should I do if I think I have preterm labor?
6. What should I consider emergency situations?
7. What is Alere's obstetrical home care program?
8. What services does Alere offer for preterm labor management?
9. What are the components of Alere's obstetrical home care services for preterm management?
10. Is home uterine activity monitoring clinically effective? I understand that ACOG questions its clinical usefulness.
11. Is home uterine activity monitoring cost-effective?
12. What are the benefits of using Alere's services?
13. Why would my doctor refer me to Alere?
14. Why monitor uterine activity on a daily basis?
15. Does insurance cover Alere's services?

For the Doctor:

1. Why should I consider referring my patients to Alere? I teach them to palpate their uterine contractions.
2. I schedule more frequent office visits for my complicated patients. That seems to work well. Why should I use your service?
3. As a physician, how do I know that Alere's services will accommodate my plan of care?

FAQs for the Patient:

1. Who is at risk for preterm birth?

The following conditions may be associated with an increased likelihood of preterm birth:

• Previous preterm labor or delivery
• Abnormally shaped uterus
• Previous uterine surgery
• Two or more second trimester abortions or miscarriages
• Incompetent cervix, cone biopsy, large fibroids
• Current multiple-gestation pregnancy
• Severe kidney or urinary tract infections
• Cervical dilation or effacement before 36 weeks of pregnancy
• Excessive uterine contractions before 36 weeks
• Vaginal bleeding and too much or too little amniotic fluid
• Age less than 18 or greater than 35
• Unusual physical or mental stress

If you have any of these conditions, you should discuss them with your doctor.

2. What is considered preterm?

The duration of pregnancy is calculated from the first day of your last menstrual period. Your due date is calculated as being 40 weeks from your last period, but every delivery occurring beyond the 37th week is considered full term. To understand what preterm is, it is necessary to divide the pregnancy into three stages: first state, from the first day of the last menstrual period to the 19th week; second state, from the 20th to the 36th week; and third state, from the 37th to the 40th week of pregnancy.

If pregnancy ends prior to 20 weeks of gestation, it is considered miscarriage or an abortion (spontaneous or therapeutic). If pregnancy ends after the 20th week, it is considered delivery. If the delivery occurs during the period from 20 to 36 weeks, it is a preterm birth. If delivery occurs at or beyond 37 weeks of pregnancy, it is a term birth.

3. What is labor?

Labor is the process by which the uterus (womb) contracts or tightens in a regular pattern and causes the cervix (the mouth of the womb) to open and prepare for delivery. Labor is diagnosed when both uterine contractions and cervical change occur. The changes in the cervix can be evaluated during a pelvic examination by your healthcare provider. The cervical changes that would occur during labor include:

• Softening or change in the consistency of the cervix
• Effacement or thinning/shortening of the cervix
• Dilation or opening of the cervix

These changes may be difficult to detect even for an experienced examiner. Your role in early identification of labor is to monitor for uterine contractions and report signs of preterm labor.

4. What is preterm labor? What is the cause of preterm labor?

The cause of preterm labor is not completely understood. It is known that certain situations are associated with preterm labor and may increase your risk for early delivery. Very common factors would include carrying more than one baby (twins or triplets) or having had a preterm delivery in the past.

At this time, preterm labor can't be prevented. We can only do the next best thing − identify it early and treat it effectively to help the pregnancy continue. Early recognition of the signs of preterm labor may result in better management of your pregnancy. You probably have a better sense of the chances occurring within your body than anyone else does.

The following are signs that occur during preterm labor. However, they can also be a very normal part of a healthy pregnancy. What you need to keep in mind as you go over these signs is what may represent a change from your normal pattern or experience.

• Uterine contractions. The uterus (womb) is composed of muscle fibers. A uterine contraction is the tightening of the muscle within the uterus. Using your fingertips to feel the uterus, you should be able to indent your uterus when it is relaxed. During a contraction, you feel your uterus tighten and become hard. Contractions occur normally throughout pregnancy. They are usually painless and they can occur at any time. Certain activities such as changing your position or having a full bladder may cause a contraction. The type of contraction you will have with preterm labor may also be painless, but there is often a pattern of tighenings. Your uterus will feel hard over the entire surface, and this tightening may occur every 15 minutes or closer. Each contraction may last from 40 seconds up to 1 1/2 to two minutes.
• Menstrual-like cramps. These are felt low in the abdomen, just above the pubic bone. The cramping may be rhythmic, feeling like waves or fluttering. You may also feel constant cramping.
• Lower, dull backache. This backache is located mainly in the lower back and may radiate to the sides or front. It may be rhythmic or constant, and often is not relieved by change of position.
• Pelvic pressure. You may feel pressure or fullness in the pelvic area, in your back or your thighs. It may feel as though the baby is going to "fall out."
• Intestinal cramps. These may occur in the presence or absence of diarrhea. You may have the feeling of "gas pains."
• Increase or change in vaginal discharge. The amount may be more than that which is normal to you. The consistency may change to mucous or water. The color may become pink or brown-tinged.
• Feeling that something is not right. Many women with preterm labor have a sense that things do not feel as they did before.

5. What should I do if I think I have preterm labor?

1. Go to the bathroom and empty your bladder.
2. Maintain adequate fluid intake as instructed by your healthcare provider.
3. Rest on your LEFT side, lying down; record frequency of uterine contractions.
4. Call your healthcare provider.

6. What should I consider emergency situations?

Sometimes, a problem can occur that needs attention right away. If you notice any signs below, CALL YOUR DOCTOR IMMEDIATELY:

• Bleeding. If you experience vaginal bleeding, a large gush or steady stream of bright red blood, it is an emergency. Get help immediately, lie on your side and put your feet higher than your head. Save the pads or cloths used to catch the blood.
• Rupture of the bag of water (amniotic sac). Sometimes the bag of water around the baby will rupture early. If you notice a gush of fluid or steady trickle of fluid, you should call your doctor.
• Severe stomach pain. If you have sharp, constant, severe pain that doesn't go away when you change position, with or without contractions or bleeding, notify your doctor.

7. What is Alere's obstetrical homecare program?

If you are having preterm labor, your doctor may prescribe the Alere Preterm Labor Program. Nurses and pharmacists with experience in caring for pregnant women will help you learn to recognize the signs and symptoms of preterm labor. The comprehensive program allows Alere, along with your help, to watch for the earlier signs of preterm labor and to notify your doctor of any change in your condition. The Alere Preterm Labor Program allows you to receive the optimum level of care in your home.

8. What services does Alere offer for preterm labor management?

Alere offers a continuum of care, based on a physician's prescription, including the following options:

• Home uterine activity monitoring with nursing surveillance and support
• Home uterine activity monitoring with oral tocolytics
• Subcutaneous tocolytic therapy

9. What are the components of Alere's obstetrical homecare services for preterm management?

Home Uterine Activity Monitoring (HUAM) with Nursing Support and Surveillance

1. Patient education on signs/symptoms of preterm labor

• Monitoring and assessment of uterine activity
• Blood pressure and weight monitoring, as ordered
• Dietary assessment, as ordered
• 24-hour nursing support
• Trended reports of clinical data

2. HUAM with Oral Tocolysis

All of the above, plus:

• All protocols of HUAM
• Pulse monitoring
• Assessment of tocolytic side effects

3. Subcutaneous Tocolytic Therapy

• All protocols of HUAM with Oral Tocolysis (above)
• Use of infusion pump
• Tocolytic medication and supplies
• Pharmacy consultations

10. Is home uterine activity monitoring clinically effective? I understand that ACOG questions its clinical usefulness.

Home uterine activity monitoring has proven effective in increasing birth weights, prolonging pregnancy and reducing NICU days for the infant. Because ACOG is focusing on preterm delivery rates rather than on improved pregnancy outcomes, the most recent Committee Option (#172) does not recommend the use of home uterine activity monitoring. This recommendation was made in spite of the fact that seven of the 10 studies highlighted in the opinion concluded that home uterine activity monitoring was beneficial as measured by earlier detection of preterm labor, pregnancy prolongation and improved pregnancy outcomes. Improved pregnancy outcomes included increased gestational age at delivery, increased birth weight and reduced nursery stays.

11. Is home uterine activity monitoring cost-effective?

Yes. Home uterine activity monitoring has been shown to significantly reduce the costs associated with hospitalizations before delivery and for the infant after delivery. In a study initiated by a major insurance carrier, the overall savings for 79 high-risk pregnancies using home uterine activity monitoring was $11,500 per pregnancy. In another study, the savings for 34 patients receiving home uterine activity monitoring services was $4,700 per pregnancy.

Alere's data also confirm cost savings: for each $1 spent in home preterm labor management services, $3 to more than $5 is saved by reducing antepartum and neonatal nursery days.

12. What are the benefits of using Alere's services?

1. Experience/expertise in obstetrical homecare

• Alere has provided preterm labor management services to more than 300,000 patients.

2. Increased Satisfaction

• Customized protocols based on patient/physician needs
• Reduced medication/compliance issues
• Patient participation in care; increased opportunity to remain at home
• 24-hour patient support from obstetrical clinicians

3. Improved pregnancy outcomes

• Increased birth weights
• Increased gestational age at delivery
• Reduced nursery days

4. Cost Savings

• Reduced antepartum/nursery days

5. FDA has approved one of Alere’s monitoring devices for use by women at risk for preterm birth.

13. Why would my doctor refer me to Alere?

Patients accurately perceive only 15 percent of their preterm contractions. It has been reported that home uterine activity monitoring devices accurately detect uterine contractions even at early gestational ages. In order to successfully halt a labor, uterine contractions must be detected before advanced cervical dilation occurs.

Although the cervix needs to reach 10 centimeters for birth to occur, it is almost impossible to halt labor with any form of treatment after four centimeters. Preterm labor can be subtle. Information collected by the home uterine activity monitoring device and interpreted by the nurse can assist in the early identification of increased uterine activity so that treatment has more of a chance to be effective.

14. Why monitor uterine activity on a daily basis?

Uterine activity is monitored daily for two reasons:

• To identify abnormal contraction patterns
• To identify the "crescendo" of uterine activity that precedes delivery
• Early identification of changes in uterine activity patterns permits early intervention to prolong pregnancy

15. Does insurance cover Alere's services?

Yes, in most cases. Alere has more than 700 managed care contracts that cover preterm labor management services. Alere will check the patient's insurance prior to initiation of service.

FAQs for the Physician:

1. Why should I consider referring my patients to Alere? I teach them to palpate their uterine contractions.

Patients accurately perceive only 15 percent of their contractions. It has been reported that home uterine activity monitoring devices accurately detect uterine contractions even at early gestational ages. In order to successfully halt preterm labor, uterine contractions must be detected before advanced cervical dilation occurs.

2. I schedule more frequent office visits for my complicated patients. That seems to work well. Why should I use your service?

Alere's service allows the referring physician to keep a more watchful eye on complicated patients between office visits. Through daily surveillance and more frequent clinical assessment, Alere's obstetrical nurses stay abreast of any significant changes in the patient's condition. This assures that the referring physician always has current objective information on the patient's clinical status, which allows intervention in the most timely manner possible.

3. As a physician, how do I know that Alere's services will accommodate my plan of care?

Alere has developed and refined our services over the years to accommodate physician plans of care. As such, our program provides comprehensive obstetrical nursing care complemented by a full-time pharmacy staff experienced in obstetrics. Our focus is on patient assessment, subjective as well as objective clinical data, and education. We are expert in early identification of changes in a patient's clinical status. And we provide thorough client-specific utilization and outcome reports.

Our services are distinguished by their depth and breadth:

• Experienced perinatal nurses to assist high-risk obstetrical patients
• 24/7 nursing and pharmacy staff
• Initial one-on-one comprehensive nursing education
• Ongoing education to address patient needs and physician's treatment plan
• Written patient education materials
• Surveillance of high-risk patients who require additional time and resources
• Individual and aggregate outcome reports by practice and by provider