Recruiting

Fetal EKG

Sponsor:

Mindchild Medical Inc.

Code:

NCT02320279

Conditions

Labor

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fetal Heart Rate Monitor

Study Details

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.

Conditions

Labor

Study ID

NCT02320279

Start date

Oct, 2013

Status verified date

Nov, 2021

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

900 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Fetal Heart Rate Monitor

Use of a system that monitors fetal heart rate through use of fetal EKG read using abdominal electrodes

Primary outcome measure

  • Quantitative FHR [ Time Frame: During Labor ]

Central Contacts and Locations

Central contacts

Adam Wolfberg, MD

781-624-8000adam.wolfberg@mindchild.com

Locations

South Shore Hospital

Recruiting

South Weymouth, Massachusetts, United States, 02190

Principal Investigator:

Adam Wolfberg, MD

More Information

Sponsor

Mindchild Medical Inc.

Last update posted

Nov 16, 2021

Last verified

Nov, 2021

Keywords

  • Fetal Heart Rate
  • Fetal EKG
  • FHR tracing
  • fetal R-waves

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mindchild Medical Inc. on 2021-11-16.