Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 11:23 PM
Study NCT ID:
NCT01131260
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2010-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fetal ST Segment and T Wave Analysis in Labor
Sponsor:
The George Washington University Biostatistics Center
Organization:
Study Overview
Official Title:
A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN)
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAN
Brief 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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10HD021410 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD027869 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD027917 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD053118 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD027915 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD034208 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD053097 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD040500 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD040485 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD040544 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD040545 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD040560 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD040512 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01HD036801 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD068268 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD068282 | NIH | None | https://reporter.nih.gov/quic… | View |