Fetal Intrapartum Heart Rate FHR/ECG Study
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.
Abnormality in Fetal Heart Rate or Rhythm
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||1 Day|
|Official Title:||Fetal Intrapartum Heart Rate FHR/ECG Study|
- Quantitative FHR patterns predictive of adverse neonatal outcome [ Time Frame: During Labor ] [ Designated as safety issue: No ]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.
- Uterine contraction measurement [ Time Frame: During Labor ] [ Designated as safety issue: No ]Uterine contraction monitoring using skin surface electrodes
Biospecimen Retention: Samples Without DNA
1) umbilical cord arterial and venous blood; 2)placenta for pathological evaluation.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
The purpose of the study is to:
- evaluate the association between serologic markers of neonatal brain injury and the specific FHR monitoring findings using the investigational device;
- 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;
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01881685
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: James Greenberg, MD 617-732-5500|
|Principal Investigator: James Greenberg, MD|
|United States, Ohio|
|Summa Center for Women's Health Research||Recruiting|
|Akron, Ohio, United States, 44304|
|Contact: Amy Alexander, BS 330-375-6119|
|Principal Investigator: Timothy Drake, MD|
|Principal Investigator:||Timothy Drake, MD||Summa Center for Women's Health Research|