Status:
COMPLETED
Fetal Intrapartum Heart Rate FHR/ECG Study
Lead Sponsor:
Mindchild Medical Inc.
Conditions:
Abnormality in Fetal Heart Rate or Rhythm
Eligibility:
FEMALE
18+ years
Brief Summary
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.
Detailed Description
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. investigat...
Eligibility Criteria
Inclusion
- 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
- Speakers of languages other than English
- Gestational age less than 24 weeks 0 days
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01881685
Start Date
March 1 2013
End Date
December 1 2015
Last Update
September 18 2019
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Summa Center for Women's Health Research
Akron, Ohio, United States, 44304