The finance world is abuzz with the prospect of a new lucrative pharmaceutical market: the preterm birth diagnostic test kit market. Market analysts expect recent innovations and U.S. Food and Drug Administration (FDA) approval to create a demand among hospitals and other medical providers who may be able to test reliably for the possibility of preterm birth for the first time in medical history.
Recent Scientific Advances Make it Possible
Until recently, the best way to predict imminent preterm labor was to use a test with a negative predictive value, which is a test that measured a woman’s likelihood that she wouldn’t experience preterm birth. Though it was the best option available, it failed to accurately predict many preterm births, and mothers and newborns suffered.
Scientists have recently developed two new tests that may predict preterm birth more accurately, and hopefully provide opportunities for at-risk mothers to take preventative steps and carry their babies to term.
The FDA approved the first new style of test in April, 2018. It is a cervicovaginal placental alpha macroglobulin-1 (PAMG-1) marketed under the brand name Parto Sure from manufacturer Qiagen. It assesses the risk of preterm birth in women with the symptoms of preterm labor with a greater accuracy that any other test doctors could use.
The PAMG-1 predicts the risk of preterm labor with a positive predictive value, or with the likelihood a woman will give spontaneous preterm birth. It has vastly improved doctors’ evaluation and subsequent treatment options for pregnant patients with the symptoms of preterm labor.
Even more recently, scientists identified genetic markers in a mothers’ cell-free RNA that are positive predictors of preterm birth. When used in conjunction with ultrasounds, the studies of this new blood test are promising. More cost-effective than other methods, the blood test should be very popular among medical providers and patients. The new test is so promising, in fact, that the financial as well as the medical world is talking about it.
Based on the number of reports currently circulating, it seems likely that preterm labor diagnostic test kits will be in high demand among obstetric providers. Hopefully, the new methods will lower the overall rate of preterm birth in the U.S.
Preterm Birth in the U.S.
Worldwide, preterm birth is the leading cause of death in children under the age of five. Of these, 75 percent of preterm births can be prevented with cost-effective medical intervention if they are diagnosed in time.
Preterm birth occurs when a baby is born before it has reached 37 weeks gestation. According to the Centers for Disease Control and Prevention (CDC), 1 in 10 American births was a preterm birth in 2016. Though rates declined from 2007 to 2014, 2016 marked the 2nd year in a row that rates of preterm birth rose in America. The new diagnostic methods are hitting the market just in time to hopefully reverse this rising trend.
Preterm birth is so dangerous to babies because hugely important development takes place in the final weeks in the womb. The lungs, liver, and brain need the full term of pregnancy to develop correctly. Babies born too early are more likely to suffer disability or die, especially if they were born before 32 weeks.
About 17 percent of infant deaths occur because of preterm birth. Babies who survive preterm birth are vulnerable to a variety of problems, including:
- Breathing problems
- Feeding problems, both with breastfeeding and bottle-feeding
- Cerebral palsy
- Developmental delays
- Speech problems
- Vision problems
- Hearing problems
- Susceptibility to infection
Preterm birth is hard on mothers and hard on families. It is a very stressful situation for both mother and baby to spend baby’s first few weeks or months of life in the hospital. The specialized medical care required also creates a heavy financial burden on families. These are among the reasons why advances in diagnostics are so important.
Causes of Preterm Labor
Doctors can’t always say what causes preterm birth. Sometimes it seems to occur spontaneously, or as a result of certain medical conditions. Other times, it is caused by medical negligence, such as a doctor not recognizing or treating complications.
There are certain risk factors that increase the likelihood of preterm birth, which is why it is so important for mothers to communicate with their doctors about their health. Risk factors that increase the likelihood of preterm birth include:
- Age – Mothers under 20 and over 35 have an increased risk.
- Race – African-American mothers have an almost doubled risk of giving birth early.
- Economic Status – Low income women without access to adequate healthcare are at an increased risk
- Medical History – Prior preterm birth increases the risk of future premature births.
- Maternal Infections – Maternal infections increase the risk of delivering preterm.
- Preeclampsia – Preeclampsia almost always results in premature birth.
- Multiples – Carrying multiple babies (twins, etc) increases the risk.
- Lifestyle – Substance abuse and tobacco use increases the risk of preterm birth.
There are numerous factors that may contribute to an increased risk of preterm birth. Speak with your doctor about concerns related to any of these, or other, factors.
Preventing Preterm Labor and Birth
The best prevention of preterm birth is for a mother to improve her general health and to seek regular medical attention. Specifically, mothers can improve the health of their pregnancies by doing the following:
- Quit smoking
- Maintain a healthy weight
- Remain active throughout pregnancy
- Avoid alcohol and drugs
- Seek regular prenatal care and follow all your provider’s instructions
- Seek medical attention immediately if you suspect the signs of preterm labor
- Consider progesterone supplements, especially if you have had a previous preterm birth
- Wait 18 months between pregnancies
With the advent of new diagnostic tools, it is more important than ever for pregnant women to know the signs of early labor and seek diagnosis and treatment if there is a chance they may give birth prematurely. The signs of preterm labor are:
- Regular contractions that become increasingly stronger
- Change in vaginal discharge
- Discharge of amniotic fluid (water breaking)
- Pelvic pressure like the baby is pushing down
- Ache in the lower back
- Abdominal cramps with or without diarrhea
- Cramps that seem like a menstrual period
These same signs after 37 weeks indicate regular, full-term labor as well.
Properly diagnosed, treatment for preterm labor may include several different measures intended either to delay labor or to help the baby develop quickly to increase his or her chance of survival. Treatments may include:
- Tocolytics – A medication to stop contractions for up to two days.
- Cervical Cerclage – Strong sutures sew a woman’s cervix shut to prevent the progression of labor.
- Corticosteroids – Potent steroids given to the mother via injection to help a premature baby’s lungs develop in the womb prior to birth.
- Magnesium Sulfate – A medication that may reduce a premature baby’s risk of developing cerebral palsy.
Birth Injury Attorneys Who Care
Though many causes of preterm birth and subsequent birth injury may remain unknown, medical negligence can, and sometimes does, contribute to babies being born early, or adverse events surrounding birth. Doctors are tasked with recognizing possible complications of pregnancy and taking action to prevent preterm birth. When preterm birth is imminent, doctors must make appropriate decisions in how to reduce the likelihood of complications or injuries to the baby.
Injuries to the mother or child because of a doctor’s negligence are actionable claims that should be evaluated by an experienced birth injury attorney.
At Birth Injury Guide, our attorneys are passionate about justice for the injured innocent. Healthy pregnancies should result in healthy babies. When a medical error interrupts that process, the at-fault party should be held responsible. If your child suffered a birth injury, submit our contact form online, or call 1-877-415-6603 for a free consultation.