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

Fetal Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00454012
• Other study ID #: 05046
• Status: Terminated
• Phase: N/A
• First received: March 27, 2007
• Last updated: November 7, 2009
• Start date: April 2005
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: The Cooper Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Distress

Intervention

Procedure:
• biophysical profile

Locations

Country	Name	City	State
United States	Cooper UniversityHospital	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation