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

This study is currently recruiting participants.
Verified by The Cooper Health System, March 2007

Sponsored by: The Cooper Health System
Information provided by: The Cooper Health System
ClinicalTrials.gov Identifier: NCT00454012
  Purpose

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.


Condition Intervention
Fetal Distress
Procedure: biophysical profile

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   Use of Intrapartum Biophysical Profile When Fetal Heart Rate Monitoring is Non-Reassuring in Labor

Further study details as provided by The Cooper Health System:

Estimated Enrollment:   100
Study Start Date:   April 2005
Estimated Study Completion Date:   July 2007

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.

  Eligibility
Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454012

Contacts
Contact: Meena Khandelwal, MD     856-342-2491     khandelwal-meena@cooperhealth.edu    
Contact: Clare E Hansen, RNC, BSN     856-968-7547     hansen-clare@cooperhealth.edu    

Locations
United States, New Jersey
Cooper UniversityHospital     Recruiting
      Camden, New Jersey, United States, 08103
      Contact: Meena Khandelwal, MD     856-342-2491     khandelwal-meena@cooperhealth.edu    

Sponsors and Collaborators
The Cooper Health System

Investigators
Principal Investigator:     Meena Khandelwal, MD     Cooper University Hospital    
  More Information


Publications of Results:

Study ID Numbers:   05046
First Received:   March 27, 2007
Last Updated:   March 27, 2007
ClinicalTrials.gov Identifier:   NCT00454012
Health Authority:   United States: Institutional Review Board

Keywords provided by The Cooper Health System:
non reassuring fetal heart rate tracing  
biophysical profile  
assessing fetal wellbeing  

Study placed in the following topic categories:
Signs and Symptoms
Fetal Distress

ClinicalTrials.gov processed this record on October 22, 2008




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