NCT00454012

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 10, 2009

Status Verified

March 1, 2009

First QC Date

March 27, 2007

Last Update Submit

November 7, 2009

Conditions

Fetal Distress

Keywords

non reassuring fetal heart rate tracingbiophysical profileassessing fetal wellbeing

Interventions

biophysical profilePROCEDURE

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooper UniversityHospital

Camden, New Jersey, 08103, United States

Location

Related 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. doi: 10.1016/0002-9378(80)90457-3.

    PMID: 7355965RESULT

MeSH Terms

Conditions

Fetal Distress

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Meena Khandelwal, MD

    The Cooper Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2007

First Posted

March 29, 2007

Study Start

April 1, 2005

Study Completion

December 1, 2008

Last Updated

November 10, 2009

Record last verified: 2009-03

Locations

US(1)