A new study has found that women with symptoms of preterm labor who were discharged from the hospital without a fetal fibronectin (fFN) test were more likely to deliver their baby prematurely within 3 days compared to women who were discharged with an fFN test.1 Published in the journal ClinicoEconomics and Outcomes Research, the study is reportedly one of the largest to evaluate interventions and outcomes in women presenting with symptoms of preterm labor.

James Byrne, MD, Santa Clara Valley Medical Center.

James Byrne, MD, Santa Clara Valley Medical Center.

“One in 10 infants born in the United States will be delivered prematurely, which has serious implications for the health of both the mother and the baby,” says James Byrne, MD, chairman of the department of obstetrics and gynecology at Santa Clara Valley Medical Center and a contributing author of the paper. “In fact, preterm delivery is a leading cause of infant morbidity. Unfortunately, the rate of preterm births has been increasing again in the past 2 years.

“In our study, one in five women discharged went on to deliver their baby prematurely within 3 days, and only 4% of these women received an fFN test,” Byrne adds. “This indicates a significant missed opportunity for healthcare providers to better understand patients’ risk for preterm labor and improve care management with the use of screening tools such as fFN testing.”

  • Study Details: The retrospective study is one of the first to assess the use of fFN screening through medical claims data drawn from the Inovalon medical outcomes research for effectiveness and economics registry (MORE2 registry), a national multipayer claims database that includes members enrolled in commercial plans and managed Medicaid or Medicare Advantage plans. Researchers investigated healthcare and delivery timing patterns from June 2012 through November 2015 among more than 23,000 women nationwide who went to the hospital displaying symptoms of preterm labor.
  • Key Results: The study found that only 12% of pregnant women with symptoms of preterm labor received fFN screening. Furthermore, of those who were discharged from the emergency room, one in five went on to deliver within 3 days, and almost 96% of this group was not screened for the presence of fFN. Conversely, of the women who were admitted to the hospital, 9% did not deliver during their stay, and more than 80% of these patients did not receive fFN screening.

The study also evaluated the outcomes for women who received assessment via transvaginal ultrasound (TVUS), both with and without a corresponding fFN test. The percentage of women who delivered within 3 days of being discharged was lower for those who received fFN testing only versus those who had a TVUS only, suggesting that the use of fFN testing may have added valuable information to inform patient care. The percentage of women who delivered within 3 days of being discharged was lowest among patients who had both an fFN test and a TVUS. Specifically, 1% of women who received both tests went on to deliver within 3 days compared to 3% of those who underwent fFN testing alone and 18% of those who received TVUS alone.


Edward Evantash, MD, Hologic.

“The numbers show that the need to increase fFN testing is two-fold,” says Edward Evantash, MD, medical director and vice president for medical affairs at Hologic Inc, Marlborough, Mass. “Not only will we be able to screen women at risk for preterm delivery more accurately and provide better care for her and her unborn baby, but we can also decrease unnecessary interventions and hospital admissions for those not at risk, ultimately lowering medical costs. All mothers deserve the best possible perinatal care, and the fFN test is a useful tool that should be used for those who are experiencing symptoms of preterm labor.”

The fFN test is a safe, reliable, and noninvasive assay that detects the presence of fetal fibronectin in vaginal secretions. It can help healthcare providers determine whether a woman is at risk for preterm delivery through a clinically proven predictive value. In line with Hologic’s commitment to improving women’s health and well-being, the company continues to develop a quantitative fFN test to further optimize perinatal care for women and their unborn babies. A quantitative fFN test is CE-marked and commercially available in Europe but is not yet available for sale for diagnostic use in the United States.

Hologic was a sponsor of the MORE2 registry study. Initial results were presented at the Society for Maternal-Fetal Medicine’s 37th Annual Pregnancy Meeting in Las Vegas in January 2017. For more information, visit Hologic.


  1. Blackwell SC, Sullivan EM, Petrilla AA, Shen X, Troeger KA, Byrne JD. Utilization of fetal fibronectin testing and pregnancy outcomes among women with symptoms of preterm labor. ClinicoEconomics and Outcomes Research. 2017;9:585–594; doi: 10.2147/ceor.s141061.