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

Primary Purpose

Fetal Distress

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
biophysical profile
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Distress focused on measuring non reassuring fetal heart rate tracing, biophysical profile, assessing fetal wellbeing

Eligibility Criteria

14 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cooper UniversityHospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 27, 2007
Last Updated
November 7, 2009
Sponsor
The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00454012
Brief Title
Use of Intrapartum Biophysical Profile When Fetal Heart Rate Monitoring is Non-reassuring in Labor
Official Title
Use of Intrapartum Biophysical Profile When Fetal Heart Rate Monitoring is Non-reassuring in Labor
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Terminated
Why Stopped
poor enrolment
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The Cooper Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Distress
Keywords
non reassuring fetal heart rate tracing, biophysical profile, assessing fetal wellbeing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
biophysical profile

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meena Khandelwal, MD
Organizational Affiliation
The Cooper Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooper UniversityHospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7355965
Citation
Manning FA, Platt LD, Sipos L. Antepartum fetal evaluation: development of a fetal biophysical profile. Am J Obstet Gynecol. 1980 Mar 15;136(6):787-95. doi: 10.1016/0002-9378(80)90457-3.
Results Reference
result

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

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