Fetal Intrapartum Heart Rate FHR/ECG Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01881685

Enrollment

400

Registered

2013-06-20

Start date

2013-03-31

Completion date

2015-12-31

Last updated

2019-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormality in Fetal Heart Rate or Rhythm

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results