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Fetal ST Segment and T Wave Analysis in Labor

NCT01131260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11108

Last updated 2019-07-15

Study results available
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Summary

The purpose of this research is to test a new instrument, called a fetal STAN monitor, that may be used during labor to monitor the electrical activity of the baby's heart. This new instrument is designed to help the doctor determine how well the baby is doing during labor. It will be used along with the existing electronic fetal monitor used to measure the baby's heart rate and the mother's contractions during birth. The specific purpose of this research study is to see if this new instrument (fetal STAN monitor) will have an impact on newborn health.

Conditions

  • Pregnancy
  • Obstetric Labor
  • Parturition

Interventions

DEVICE

fetal STAN monitor

The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG.

Sponsors & Collaborators

  • Neoventa Medical

    collaborator UNKNOWN

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • The George Washington University Biostatistics Center

    lead OTHER

Principal Investigators

  • Menachem Miodovnik, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • Rebecca Clifton, PhD · George Washington University Biostatistics Center

  • George Saade, MD · University of Texas

  • Michael Belfort, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-04-30
Completion
2014-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01131260 on ClinicalTrials.gov