The objective of the study is to evaluate the association between certain markers in the blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the device under study.
The purpose of the study is to: 1. evaluate the association between serologic markers of neonatal brain injury and the specific FHR monitoring findings using the investigational device; 2. investigate the relationship between selective serotonin reuptake inhibitor (SSRI) antidepressants and the QT interval of the fetal heart. Specifically, examine the potential association between maternal SSRI use and the fetal QT interval,and; 3. develop the capacity to measure uterine contractions during labor using non-invasive electrodes that measure the electrical signal from the uterine muscle. For this study, the investigational device will not be used to diagnose or treat as it will be used in concert with the current standard of care monitors.
Study Type
OBSERVATIONAL
Enrollment
400
Brigham and Women's Hospital
Boston, Massachusetts, United States
Summa Center for Women's Health Research
Akron, Ohio, United States
Quantitative FHR patterns predictive of adverse neonatal outcome
1)quantitative analysis of fetal heart-rate (FHR) data recorded during labor using advanced mathematical techniques, including pattern-recognition analysis using EKG stickers applied to the maternal abdomen.
Time frame: During Labor
Uterine contraction measurement
Uterine contraction monitoring using skin surface electrodes
Time frame: During Labor
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