1. Placental Alpha Microglobulin-1 Compared With Fetal Fibronectin to Predict Preterm Delivery in Symptomatic Women.
- Author
-
Wing, Deborah A, Haeri, Sina, Silber, Angela C, Roth, Cheryl K, Weiner, Carl P, Echebiri, Nelson C, Franco, Albert, Pappas, Lanissa M, Yeast, John D, Brebnor, Angelle A, Quirk, J Gerald, Murphy, Aisling M, Laurent, Louise C, Field, Nancy T, and Norton, Mary E
- Subjects
Fetal Blood ,Placenta ,Humans ,Premature Birth ,Alpha-Globulins ,Fibronectins ,Prospective Studies ,Predictive Value of Tests ,Gestational Age ,Pregnancy ,Labor Stage ,First ,Adult ,United States ,Female ,Statistics as Topic ,Cervical Length Measurement ,Contraception/Reproduction ,Prevention ,Preterm ,Low Birth Weight and Health of the Newborn ,Clinical Research ,Pediatric ,Perinatal Period - Conditions Originating in Perinatal Period ,Infant Mortality ,Detection ,screening and diagnosis ,4.2 Evaluation of markers and technologies ,Reproductive health and childbirth ,Good Health and Well Being ,Paediatrics and Reproductive Medicine ,Obstetrics & Reproductive Medicine - Abstract
ObjectiveTo compare the rapid bedside test for placental α microglobulin-1 with the instrumented fetal fibronectin test for prediction of imminent spontaneous preterm delivery among women with symptoms of preterm labor.MethodsWe conducted a prospective observational study on pregnant women with signs or symptoms suggestive of preterm labor between 24 and 35 weeks of gestation with intact membranes and cervical dilatation less than 3 cm. Participants were prospectively enrolled at 15 U.S. academic and community centers. Placental α microglobulin-1 samples did not require a speculum examination. Health care providers were blinded to placental α microglobulin-1 results. Fetal fibronectin samples were collected through speculum examination per manufacturer requirements and sent to a certified laboratory for testing using a cutoff of 50 ng/mL. The coprimary endpoints were positive predictive value (PPV) superiority and negative predictive value (NPV) noninferiority of placental α microglobulin-1 compared with fetal fibronectin for the prediction of spontaneous preterm birth within 7 days and within 14 days.ResultsOf 796 women included in the study cohort, 711 (89.3%) had both placental α microglobulin-1 and fetal fibronectin results and valid delivery outcomes available for analysis. The overall rate of preterm birth was 2.4% (17/711) within 7 days of testing and 4.2% (30/711) within 14 days of testing with respective rates of spontaneous preterm birth of 1.3% (9/703) and 2.9% (20/701). Fetal fibronectin was detected in 15.5% (110/711), and placental α microglobulin-1 was detected in 2.4% (17/711). The PPVs for spontaneous preterm delivery within 7 days or less among singleton gestations (n=13) for placental α microglobulin-1 and fetal fibronectin were 23.1% (3/13) and 4.3% (4/94), respectively (P
- Published
- 2017