Fetal Intrapartum Heart Rate FHR/ECG Study

Completed

• Conditions: Abnormality in Fetal Heart Rate or Rhythm

• Registration Number: NCT01881685
• Lead Sponsor: Mindchild Medical Inc.

Brief Summary

The objective of the study is to evaluate the association between certain markers in the blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the device under study.

Detailed Description

The purpose of the study is to:

1. evaluate the association between serologic markers of neonatal brain injury and the specific FHR monitoring findings using the investigational device;

2. investigate the relationship between selective serotonin reuptake inhibitor (SSRI) antidepressants and the QT interval of the fetal heart. Specifically, examine the potential association between maternal SSRI use and the fetal QT interval,and;

3. develop the capacity to measure uterine contractions during labor using non-invasive electrodes that measure the electrical signal from the uterine muscle.

For this study, the investigational device will not be used to diagnose or treat as it will be used in concert with the current standard of care monitors.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-20
• Status Verified: 2014-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Pregnant women in their third trimester and Women in labor (the progressive effacement and dilatation of the cervix) who are having their fetus' heart rate monitored continuously will form the eligible population for recruitment into our study
• 18 years old or older
• Women with the diagnosis of fetal intrauterine growth restriction may be included.

Exclusion Criteria

• Speakers of languages other than English
• Gestational age less than 24 weeks 0 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative FHR patterns predictive of adverse neonatal outcome	During Labor	1)quantitative analysis of fetal heart-rate (FHR) data recorded during labor using advanced mathematical techniques, including pattern-recognition analysis using EKG stickers applied to the maternal abdomen.

Secondary Outcome Measures

Name	Time	Method
Uterine contraction measurement	During Labor	Uterine contraction monitoring using skin surface electrodes

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Summa Center for Women's Health Research; 🇺🇸 Akron, Ohio, United States