## Protocol Section
### Identification Module
**NCT ID:** NCT05399979

**Brief Title:** Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach

**Official Title:** Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach

#### Organization Study ID Info
**ID:** 1567908
#### Organization
**Class:** OTHER
**Full Name:** Augusta University
### Status Module
#### Completion Date
**Date:** 2022-05-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-06-03

**Type:** ACTUAL

**Last Update Submit Date:** 2022-06-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-05-05

**Type:** ACTUAL

#### Start Date
**Date:** 2021-06-09

**Type:** ACTUAL

**Status Verified Date:** 2022-06

#### Study First Post Date
**Date:** 2022-06-01
**Type:** ACTUAL
**Study First Submit Date:** 2022-05-27
**Study First Submit QC Date:** 2022-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Augusta University

#### Responsible Party

**Investigator Affiliation:** Augusta University

**Investigator Full Name:** Efrain Riveros Perez, MD

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study aims to perform statistical inference and prediction of changes in fetal heart rate during active labor in healthy pregnant women by comparing three different machine learning methods

**Detailed Description:** Purpose: This study aims to perform statistical inference and prediction of changes in fetal heart rate during active labor in healthy pregnant women by comparing three different machine learning methods. Methods: A retrospective analysis of 1077 healthy laboring parturients receiving neuraxial analgesia was conducted. We compared a principal components regression model with treebased random forest, ridge regression, multiple regression, a general additive model, and elastic net in terms of prediction accuracy and interpretability for inference purposes.

### Conditions Module

**Conditions:**

- Fetal Bradycardia

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 1077

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Labor Neuraxial Analgesia

**Name:** Labor Neuraxial Analgesia

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** fetal heart rate under 120 lpm for more than 10 minutes

**Measure:** fetal bradycardia

**Time Frame:** 15 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Older than 18 years
* Pregnancy requiring labor analgesia
* Active labor
* Request of neuraxial analgesia per patient and/or obstetrician
* Received combined spinal-epidural technique

Exclusion Criteria:

* Uterine tachysystole before neuraxial analgesia.
* Baseline blood pressure \<90/60 mmHg.
* Third trimester hemorrhage
* Eclampsia
* Allergies to local anesthetics or fentanyl.
* Maternal fever.
* Pruritus before performance of neuraxial analgesia

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** -Pregnant patients admitted to the labor and delivery unit of an academic center

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Augusta

**Country:** United States

**Facility:** Augusta University Medical Center

**State:** Georgia

**Zip:** 30907

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5196

- Name: Bradycardia

- Relevance: HIGH

- As Found: Bradycardia

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001919

- Term: Bradycardia

### Misc Info Module

- Version Holder: 2024-05-24
