Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
900 participants
OBSERVATIONAL
2013-10-31
2023-12-31
Brief Summary
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Detailed Description
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* Specific Aim 2: To develop the capacity to measure fetal cardiac data using EKG sensors applied to the maternal abdomen during labor.
* Specific Aim 3: To validate prenatal non-invasive measurement of the fetal QTc interval.
* Specific Aim 4: To develop and validate the capacity to measure uterine contractions using the uterine EMG signal recorded from maternal skin-surface electrodes.
* Specific Aim 5: Collect clinical data related to medication usage and hypoxia.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Women in labor
Pregnant women, women in labor, and women who are admitted to labor and delivery for scheduled c-sections will form the eligible population for recruitment into our study.
Fetal Heart Rate Monitor
Use of a system that monitors fetal heart rate through use of fetal EKG read using abdominal electrodes
Interventions
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Fetal Heart Rate Monitor
Use of a system that monitors fetal heart rate through use of fetal EKG read using abdominal electrodes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years old or older.
* Gestational age of 24-42 weeks.
* Any method of fetal heart rate monitoring.
* Pregnant women in labor as well as women who are not in labor.
* Pregnant women who are admitted to labor and delivery for scheduled c-sections.
Exclusion Criteria
* Women under sedation or systemic anesthesia, and women who have diminished cognitive capacity
* Women in extremis (in severe pain, etc.)
* Women who are using the Mindchild device for clinical monitoring.
18 Years
FEMALE
No
Sponsors
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Mindchild Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Adam Wolfberg, MD
Role: PRINCIPAL_INVESTIGATOR
South Shore Hospital
Locations
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South Shore Hospital
South Weymouth, Massachusetts, United States
Countries
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Central Contacts
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Other Identifiers
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South Shore Fetal EKG study
Identifier Type: -
Identifier Source: org_study_id