Fetal Intrapartum Heart Rate FHR/ECG Study

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.

Study Overview

• Status: Completed
• Conditions: Abnormality in Fetal Heart Rate or Rhythm

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Center for Women's Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women in labor who are having their fetus' heart rate monitored continuously

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative FHR patterns predictive of adverse neonatal outcome	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.	During Labor

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uterine contraction measurement	Uterine contraction monitoring using skin surface electrodes	During Labor

Collaborators and Investigators

• Sponsor: Mindchild Medical Inc.
• Investigators: Principal Investigator: Timothy Drake, MD, Summa Center for Women's Health Research

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (Estimate): June 20, 2013

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: RP#12018