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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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | During Labor |
| Measure | Description | Time Frame |
|---|---|---|
| Uterine contraction measurement | Uterine contraction monitoring using skin surface electrodes | During Labor |
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Inclusion Criteria:
Exclusion Criteria:
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Women in labor who are having their fetus' heart rate monitored continuously
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Drake, MD | Summa Center for Women's Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Summa Center for Women's Health Research |
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1) umbilical cord arterial and venous blood; 2)placenta for pathological evaluation.
| Akron |
| Ohio |
| 44304 |
| United States |