The Fetal EKG Study



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:11/19/2017
Start Date:October 2013
End Date:December 2018
Contact:Adam Wolfberg, MD
Email:adam@mindchild.com
Phone:781-624-8000

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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.

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.

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 (pushing, in severe pain, etc.)
We found this trial at
1
site
South Weymouth, Massachusetts 02190
Principal Investigator: Adam Wolfberg, MD
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from
South Weymouth, MA
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