The Fetal EKG Study

NCT02320279 | Unknown

• 1 other identifier: South Shore Fetal EKG study
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Quantitative FHR

  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.

  During Labor

Secondary Outcomes (1)

• Uterine contractions

  During labor

Study Arms (1)

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.

Device: Fetal Heart Rate Monitor

Interventions

Fetal Heart Rate Monitor DEVICE

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

Also known as: Mindchild Meridian Fetal Heart Rate System

Women in labor

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. These women will be identified by a study staff-member who will ask on-call physicians, midwives, and nurses working on Labor and Delivery

You may qualify if:

• Women who are pregnant or in labor who are having their fetus' heart rate monitored continuously and able to consent
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mindchild Medical Inc.: lead

Study Sites (1)

South Shore Hospital

South Weymouth, Massachusetts, 02190, United States

RECRUITING

Study Officials

• Adam Wolfberg, MD

  South Shore Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Wolfberg, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 19, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

US (1)