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

This study has been terminated.
(poor enrolment)
Sponsor:
Information provided by:
The Cooper Health System
ClinicalTrials.gov Identifier:
NCT00454012
First received: March 27, 2007
Last updated: November 7, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention
Fetal Distress
Procedure: biophysical profile

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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: December 2008
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

Locations
United States, New Jersey
Cooper UniversityHospital
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
The Cooper Health System
Investigators
Principal Investigator: Meena Khandelwal, MD Cooper University Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00454012     History of Changes
Other Study ID Numbers: 05046
Study First Received: March 27, 2007
Last Updated: November 7, 2009
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

Additional relevant MeSH terms:
Fetal Distress
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014