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

NCT ID: NCT00454012

Last Updated: 2009-11-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2008-12-31

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.

Conditions

Fetal Distress

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

biophysical profile

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Cooper Health System

OTHER

Sponsor Role: lead

Principal Investigators

Meena Khandelwal, MD

Role: PRINCIPAL_INVESTIGATOR

The Cooper Health System

Locations

Cooper UniversityHospital

Camden, New Jersey, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 7355965 (View on PubMed)

Other Identifiers

05046

Identifier Type: -

Identifier Source: org_study_id