The Fetal EKG Study

Mindchild Medical

Status: Unknown

Conditions: Labor

Treatments: Device: Fetal Heart Rate Monitor

Study type: Observational

Funder types: Industry

Identifiers

NCT02320279

South Shore Fetal EKG study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

900 participants in 1 patient group

Women in labor

Description:

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.

Treatment:

Device: Fetal Heart Rate Monitor