Evaluation of safety and performance of CentaFlow™ in the assessment of fetal growth restriction – a randomized trial and prospective cohort study
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: OBJECTIVES: The aim was to evaluate the sensitivity and specificity of CentaFlow (CF) in a prospective multicenter study, and secondary to evaluate the safety of the CF device in a randomized multicenter study. METHODS: A sponsor-initiated multicenter randomized controlled clinical trial with termination of the randomization after enough women had been included to evaluate safety. The study proceeded as a prospective multicenter study including high-risk women (estimated fetal weight <-15 %, FGR). The first part randomized women to either standard care (SC) or SC+CF. Participants underwent CF evaluation with subsequent analysis for sensitivity and specificity for FGR at birth. Secondarily, adverse events were evaluated. Clinical assessments of fetal size conducted by midwives served as a reference. The performance of CF and SC was compared by McNemar's Test. The performance analysis of CF was done per-protocol sample. RESULTS: A total of 1,601 pregnant women were enrolled, with 886 undergoing CF evaluation. A total of 123 were FGR (<3rd percentile) at birth, of which 88 were evaluated by CF, and 117 had a clinical assessment of the estimated fetal weight. CF demonstrated no evidence of benefit for detecting FGR with a sensitivity of 50 % and specificity of 43 %. Adverse events associated with CF use were limited to minor skin irritation. McNemar's test showed SC was superior to CF regarding specificity as a screening tool (p=0.014). CONCLUSIONS: While CF was safe to use, we found no evidence that CF can be used as a predictor of FGR. Further refinement of signal analysis is necessary to enhance CFs diagnostic utility.
Source: Journal of Perinatal Medicine
Authors: Cathrine Vedel, Ane Rom, Dave Wright, Richard Farlie, Lise Hald Nielsen, Anne Hammer Lauridsen, Simone Hansen, Hanne Hegaard, Frederikke Huitfeldt Sander, Mie de Wolff, Olav Bjørn Petersen
Language: English
Subfield: Obstetrics and Gynecology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4414390574