Fetal Intrapartum Heart Rate FHR/ECG Study

Abnormality in Fetal Heart Rate or Rhythm Clinical Trial

Official title:

Fetal Intrapartum Heart Rate FHR/ECG Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881685
• Other study ID #: RP#12018
• Status: Completed
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: September 2014
• Source: Mindchild Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abnormality in Fetal Heart Rate or Rhythm
• Congenital Abnormalities

Locations

Country	Name	City	State
United States	Summa Center for Women's Health Research	Akron	Ohio
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mindchild Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Uterine contraction measurement	Uterine contraction monitoring using skin surface electrodes	During Labor