Fetal Intrapartum Heart Rate FHR/ECG Study

Mindchild Medical

Status: Completed

Conditions: Abnormality in Fetal Heart Rate or Rhythm

Study type: Observational

Funder types: Industry

Identifiers

NCT01881685

RP#12018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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