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Clinical Trials/NCT00454012
NCT00454012
Terminated
Not Applicable

Use of Intrapartum Biophysical Profile When Fetal Heart Rate Monitoring is Non-reassuring in Labor

The Cooper Health System1 site in 1 country100 target enrollmentApril 2005
ConditionsFetal Distress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fetal Distress
Sponsor
The Cooper Health System
Enrollment
100
Locations
1
Status
Terminated
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2005
End Date
December 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Spontaneous or induced labor
  • Gestational ages between 35 - 42 weeks
  • Singleton pregnancy
  • Intrapartum non-reassuring or uninterpretable FHR tracing defined as any tracing that the Labor and Delivery obstetrician is uncomfortable about or feels does not absolutely provide fetal reassurance. Inclusive FHR patterns will be repetitive late decelerations, recurrent moderate to severe variable decelerations, reduced long or short-term variability, prolonged bradycardia (\<120/min) that resolves, persistent fetal tachycardia (\>160/min for \>60 min,) or any other FHR patterns necessitating further fetal well being evaluation (like scalp pH or scalp stimulation).

Exclusion Criteria

  • Multiple gestation
  • Gestational age \< 35 weeks
  • Patient denial to undergo ultrasound examination during labor
  • Abnormal FHR tracing requiring stat delivery

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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