Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-01-01 @ 12:28 AM
Study NCT ID:
NCT00454012
Status:
TERMINATED
Last Update Posted:
2009-11-10
First Post:
2007-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Intrapartum Biophysical Profile When Fetal Heart Rate Monitoring is Non-reassuring in Labor
Sponsor:
The Cooper Health System
Organization:
Study Overview
Official Title:
Use of Intrapartum Biophysical Profile When Fetal Heart Rate Monitoring is Non-reassuring in Labor
Status:
TERMINATED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor enrolment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this research project the investigators want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor.
Detailed Description:
When you are in labor, the heart beat of your fetus is monitored continuously. The normal pattern is reactive and suggests that the fetus is doing well. When the pattern is different from reactive, it is difficult to say if the fetus is doing well or not. Previous investigators have shown that even with the most worrisome fetal heart rate pattern, only 2/1000 cases would require immediate delivery. Currently, we use invasive procedures like taking a drop of blood from fetal head to further assess how the fetus is doing or just proceed with the fastest way of delivery (which could increase the risk associated with surgery). In this research project we want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor.
Study Oversight
Has Oversight DMC:
False
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?: