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TerminatedNCT00454012Updated Nov 10, 2009

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

An interventional study of biophysical profile in Fetal Distress, sponsored by The Cooper Health System. Terminated at 1 site in United States. Open to female participants aged 14 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-11-10.

Sponsored by The Cooper Health System · Not applicable, Interventional, and Treatment

Why this study was terminated
poor enrolment
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
14 Years to 45 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Fetal Distress

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Keywords

  • non reassuring fetal heart rate tracing
  • biophysical profile
  • assessing fetal wellbeing
03

In context

Fetal Distress

35 studies on the registry are indexed under Fetal Distress; 7 are open to participants now.

This study's planned enrollment of 100 is below the median of 113 across 24 interventional studies indexed under Fetal Distress.

Browse Fetal Distress studies →

Lead sponsor

The Cooper Health System is the lead sponsor of 67 studies on the registry; 18 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Multiple gestation
  • Gestational age \< 35 weeks
  • Patient denial to undergo ultrasound examination during labor
  • Abnormal FHR tracing requiring stat delivery
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Interventions

  • Procedurebiophysical profile
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Study locations

1 site
  • Cooper UniversityHospital
    Camden, New Jersey 08103, United States
07

References and documents

Publications

  • 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. PubMed 7355965 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00454012
Lead sponsor
The Cooper Health System
First posted
Mar 29, 2007
Start date
Apr 2005
Completion
Dec 2008 (estimated)
Last update
Nov 10, 2009

Study contacts

Meena Khandelwal, MD
principal investigator · The Cooper Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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