Fetal Intrapartum Heart Rate FHR/ECG Study



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:March 2013
End Date:December 2015

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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:

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.

Inclusion Criteria:

- Pregnant women in their third trimester and Women in labor (the progressive
effacement and dilatation of the cervix) who are having their fetus' heart rate
monitored continuously will form the eligible population for recruitment into our
study

- 18 years old or older

- Women with the diagnosis of fetal intrauterine growth restriction may be included.

Exclusion Criteria:

- Speakers of languages other than English

- Gestational age less than 24 weeks 0 days
We found this trial at
2
sites
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mi
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Akron, OH
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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mi
from
Boston, MA
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