Fetal Intrapartum Heart Rate FHR/ECG Study
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|ClinicalTrials.gov Identifier: NCT01881685|
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : September 18, 2019
|Condition or disease|
|Abnormality in Fetal Heart Rate or Rhythm|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||400 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Fetal Intrapartum Heart Rate FHR/ECG Study|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
- Quantitative FHR patterns predictive of adverse neonatal outcome [ Time Frame: During Labor ]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 ]Uterine contraction monitoring using skin surface electrodes
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881685
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Ohio|
|Summa Center for Women's Health Research|
|Akron, Ohio, United States, 44304|
|Principal Investigator:||Timothy Drake, MD||Summa Center for Women's Health Research|