Background The diagnosis of labor is the most difficult and important task facing medical practitioners in maternity care today.  Knowing when labor has begun as well as predicting when it will start is important for both normal and complex pregnancies.  “Only half of the women who show signs of preterm labor actually deliver early. In others, contractions die out on their own.  But doctors have no reliable way to tell who needs potentially toxic drugs to stop contractions and who doesn’t.”1 “A NATIONAL CRISIS” “Premature birth is a serious and growing problem. It’s the leading cause of newborn death and can result in lifelong disabilities.  It affects nearly 12.8 percent of births every year, and that number has increased up from 12.3 percent in 2003.  In fact, from 1990 to 2006, the rate of premature birth has increased nearly 20 percent, accounting for more than 546,000 babies in 2006.” 2 “One out of eight babies is born prematurely in the United States. Premature birth can happen without warning and for no known reason.  In 2003, the preterm birth cost to hospitals was $18 billion, up from $14 billion in 2000. In 2005, preterm birth cost the United States society at least $26.2 billion, or $51,600 for every infant born preterm.The average first-year medical costs, including both inpatient and outpatient care, were about ten times greater for preterm infants than for term infants.” 3 Accurate diagnosis of preterm labor will allow practitioners to start treatment early in patients with true labor and avert unnecessary treatment and hospitalization of patients who are having preterm contractions, but who are not in true labor.  Currently, there are no methods to objectively and accurately evaluate the function of the uterus during pregnancy. Normal Pregnancies:  Prediction of labor is important for minimizing unnecessary hospitalizations, interventions, and expenses.  These expenses are caused by risky childbirths, which occur before the mother arrives at the hospital, or unnecessary presentation at the hospital as a result of false labor. Complex Pregnancies:  Preterm labor is the most common pregnancy complication, with 20% of all pregnant women at high risk.  In the United States alone, 12.8% of the 4.27 million babies born in the year 2006 were premature.2  In addition, preterm labor accounts for 85% of infant mortality and 50% of infant neurological disorders.3 Premature Infant Survival: Major handicaps accompany the premature infant if it survives. Complications of preterm birth include significant neurological, mental, behavioral and pulmonary problems in later life. Among the preterm survivors, the rate of neurological impairment is from 10% to 20%.3 In addition, growth retardation occurs in approximately 20% of the surviving infants.3 Early Detection: The development of some effective means to prevent or reduce the occurrence of preterm delivery depends upon understanding of the conditions that initiate labor. One of the keys to treating preterm labor is early detection.  If preterm labor is detected early, medical specialists can attempt to stop the labor process or, if unsuccessful, are better prepared to handle the premature infant. Integral to the normal birthing process and the birth of a healthy baby is the softening or “ripening” of the cervix.  Ripening is required for appropriate progress of labor and delivery of the fetus.  Presently, there is no objective method to evaluate changes associated with dilation and effacement of the cervix during pregnancy.  During pregnancy, the cervix is normally firm and closed.  At the end of pregnancy, the cervix becomes softer and dilates as the uterine contractions increase during labor.  Often, however, the cervix fails to soften and dilate with advancing labor or dilates prematurely before labor.  The exact mechanisms controlling the cervical ripening process are largely unknown. The attending physician currently monitors progress of the cervix by visual inspection or by manual examination.  These subjective tests are inadequate and vary from physician to physician. A more accurate method would be invaluable for the diagnosis of cervical problems such as premature dilation or prolonged labor due to delayed cervical dilation, as well as to determine cervical status before induction of labor.  In addition, such a method could lead to appropriate treatments to either dilate or prevent dilation of the cervix.  Treatment to increase softening in women at term has been accomplished by prostaglandins or various mechanical methods.  However, no treatment to ripen the cervix has reduced the high cesarean section rate associated with dystocia.  Research is being actively conducted by many institutions, both domestically and internationally, to address this issue. The SureTOUCH Collascope® accurately measures the ripening of the cervix – for more information, please see click on the "Technology" tab above.         NOTES: Note 1 Reference:  Science, April 30, 2004 Vol 304; p 668 Note 2 Reference: Centers for Disease Control, January 11, 2008, "Births: Preliminary Data for 2006", by Brady E. Hamilton, PhD.; Joyce A. Martin, M.P.H.; and Stephanie J. Ventura, M.A., Division of Vital Statistics, National Vital Statistics, Vol. 56, Number 7. Note 3 Reference: March of Dimes Foundation, November 2005, “Help Reduce Costs: Hospital Costs,” http://www.marchofdimes.com/prematurity/21198_10734.asp.