CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11,108 enrolled
Drug / intervention
fetal STAN monitordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01131260
NCT01131260N/ACompleted
CompareCT.gov

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

The George Washington University Biostatistics Center·interventional·Posted May 26, 2010·Updated Jul 15, 2019

In Brief

A clinical study evaluating fetal STAN monitor for Pregnancy and 2 related conditions. Completed, enrolled 11,108 participants across 13 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy, Obstetric Labor, Parturition
CountriesUnited States
CollaboratorsNeoventa Medical, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 26, 2010
Enrollment StartNov 1, 2010
Primary CompletionApr 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.1 years ago

Interventions

fetal STAN monitordevice

The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG.