## Protocol Section
### Identification Module
**NCT ID:** NCT02320279

**Brief Title:** The Fetal EKG Study

**Official Title:** The Fetal EKG Study

#### Organization Study ID Info
**ID:** South Shore Fetal EKG study
#### Organization
**Class:** INDUSTRY
**Full Name:** Mindchild Medical Inc.
### Status Module
#### Completion Date
**Date:** 2023-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-11-16

**Type:** ACTUAL

**Last Update Submit Date:** 2021-11-12

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2023-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-10

**Status Verified Date:** 2021-11

#### Study First Post Date
**Date:** 2014-12-19
**Type:** ESTIMATED
**Study First Submit Date:** 2014-12-16
**Study First Submit QC Date:** 2014-12-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Mindchild Medical Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Labor

**Keywords:**

- Fetal Heart Rate

- Fetal EKG

- FHR tracing

- fetal R-waves

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 900

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Day

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Device: Fetal Heart Rate Monitor

**Label:** Women in labor

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Women in labor

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

**Name:** Fetal Heart Rate Monitor

**Other Names:**

- Mindchild Meridian Fetal Heart Rate System

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Quantitative FHR

**Time Frame:** During Labor

#### Secondary Outcomes

**Description:** Uterine contractions will be identified by analyzing data from surface electrodes to identify patterns consistent with uterine muscle coordinated shortening. These data will be compared to data from either the external tocometer or the internal IUPC. Cross correlation analysis will be used to compare the two signals and validate the analysis of uterine EMG signal.

**Measure:** Uterine contractions

**Time Frame:** During labor

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** adam.wolfberg@mindchild.com

**Name:** Adam Wolfberg, MD

**Phone:** 781-624-8000

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** South Weymouth

**Contacts:**

***Contact 1:***

- **Name:** Adam Wolfberg, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** South Shore Hospital

**State:** Massachusetts

**Status:** RECRUITING

**Zip:** 02190

#### Overall Officials

**Official 1:**

**Affiliation:** South Shore Hospital

**Name:** Adam Wolfberg, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
