Fetal ST Segment and T Wave Analysis in Labor

2014-07-23 21:08:58 | BioPortfolio


The purpose of this research is to test a new instrument, called a fetal STAN monitor, that may be used during labor to monitor the electrical activity of the baby's heart. This new instrument is designed to help the doctor determine how well the baby is doing during labor. It will be used along with the existing electronic fetal monitor used to measure the baby's heart rate and the mother's contractions during birth. The specific purpose of this research study is to see if this new instrument (fetal STAN monitor) will have an impact on newborn health.


A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN):

Fetal ECG analysis of the ST segment (STAN) is now FDA-approved and clinically available in the United States as an adjunct for the interpretation of electronic fetal heart rate patterns. There have been a number of randomized controlled trials as well as observational studies in Europe documenting utility of this modality in terms of reducing fetal acidosis at birth, and decreasing the need for operative vaginal delivery. However, despite these endorsements, there remain concerns with the application of the technology to the United States. None of the randomized trials were performed in the United States where patient case-mix and obstetrical practice, such as the use of fetal scalp pH, differ from Europe, which may affect the impact of this technology on perinatal outcomes. Moreover, the results of the European studies are not uniformly positive.

This protocol describes a randomized controlled trial of the STAN technology as an adjunct to electronic fetal heart rate monitoring versus fetal heart rate monitoring alone.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention




fetal STAN monitor


University of Alabama - Birmingham
United States


Not yet recruiting


Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:08:58-0400

Clinical Trials [1397 Associated Clinical Trials listed on BioPortfolio]

Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy

To enable an investigation of fetal movements, the researchers have developed a multichannel ultrasound pulsed Doppler called ACTIFOETUS. This new fetal monitor includes three transducers ...

"Spontaneous Fetal EEG Recording During Labor"

This is a pilot feasibility study for a new application of an approved fetal heart rate monitoring device system. The objective of this study is to validate the feasibility of acquiring th...

Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise

Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Sy...

Refinement of LaborView

Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal well-being during labor or preparation for cesarean delivery. Current monitoring methods: tran...

The Monica Fetal Heart Monitor

The goal of this study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device...

PubMed Articles [4542 Associated PubMed Articles listed on BioPortfolio]

Using Hamiltonian Monte Carlo to estimate the log-linear cognitive diagnosis model via Stan.

The Bayesian literature has shown that the Hamiltonian Monte Carlo (HMC) algorithm is powerful and efficient for statistical model estimation, especially for complicated models. Stan, a software progr...

Adjuvant Use of Rifampin for Refractory Intrahepatic Cholestasis of Pregnancy.

Intrahepatic cholestasis of pregnancy is an incompletely understood disease that poses significant fetal risks, including stillbirth. Treatment of intrahepatic cholestasis of pregnancy is aimed at rel...

Differential effects of high-fat diets before pregnancy and/or during pregnancy on fetal growth development.

The aim of the study was to investigate the effects of high-fat diets before pregnancy and/or during pregnancy on fetal development.

Nitric oxide and the biology of pregnancy.

Nitric oxide (NO) is a key regulator of both maternal and fetal homeostasis during pregnancy, facilitating the maternal cardio-vascular changes, fetal development and growth and adaptation to extraute...

Fetal But Not Maternal Angiotensin Converting Enzyme (ACE)-2 Gene Rs2074192 Polymorphism is Associated with Increased Risk of Being a Small For Gestational Age (SGA) Newborn.

The maternal and fetal Renin-Angiotensin-System is involved in the control of pregnancy outcomes such as blood pressure control and gestational age. However, very little is known about the impact of t...

Medical and Biotech [MESH] Definitions

Round-shaped structure usually located in the upper fundus of the UTERUS in early pregnancy. It comprises EMBRYO; AMNIOTIC FLUID; and YOLK SAC. It is visible in PRENATAL ULTRASONOGRAPHY by the fifth week of pregnancy. Its size is often used to determine and monitor GESTATIONAL AGE; FETAL GROWTH; and PREGNANCY COMPLICATIONS.

A complication of pregnancy in which the UMBILICAL CORD wraps around the fetal neck once or multiple times. In some cases, cord entanglement around fetal neck may not affect pregnancy outcome significantly. In others, the nuchal cord may lead to restricted fetal blood flow, oxygen transport, fetal development, fetal movement, and complicated delivery at birth.

Pregnancy complication where fetal blood vessels, normally inside the umbilical cord, are left unprotected and cross FETAL MEMBRANES. It is associated with antepartum bleeding and FETAL DEATH and STILLBIRTH due to exsanguination.

Glycoproteins with the electrophoretic mobility of BETA-GLOBULINS, secreted by the placental TROPHOBLASTS into the maternal bloodstream during PREGNANCY. They can be detected 18 days after OVULATION and reach 200 mg/ml at the end of pregnancy. They are associated with fetal well-being.

Percutaneous transabdominal puncture of the uterus during pregnancy to obtain amniotic fluid. It is commonly used for fetal karyotype determination in order to diagnose abnormal fetal conditions.

More From BioPortfolio on "Fetal ST Segment and T Wave Analysis in Labor"

Quick Search


Relevant Topics

Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Searches Linking to this Trial