The Fetal EKG Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Labor
- Sponsor
- Mindchild Medical Inc.
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- Quantitative FHR
- Last Updated
- 4 years ago
Overview
Brief Summary
The objective is to contribute data to ongoing research activities focused on identification of EKG waveform changes in the context of clinical conditions and maternal medication use. Additionally, to develop the capacity to measure contractions more accurately and more reliably using skin-surface electrodes.
Detailed Description
Specific Aim 1: To develop a technique for the quantitative analysis of fetal heart-rate (FHR) data recorded during labor using advanced mathematical techniques, including pattern-recognition analysis. * 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women who are pregnant or in labor who are having their fetus' heart rate monitored continuously and able to consent
- •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 unable to consent
- •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.
Outcomes
Primary Outcomes
Quantitative FHR
Time Frame: During Labor
Quantitative analysis of fetal heart-rate data recorded during labor using advanced mathetmatical techniques, including pattern-recognition analysis using EKG electrodes applied to the maternal abdomen.
Secondary Outcomes
- Uterine contractions(During labor)