Fetal ST Segment and T Wave Analysis in Labor

Completed · Not applicable

Conditions studied: Pregnancy, Obstetric Labor, Parturition

In brief

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.

Key facts

Study ID

NCT01131260

Run by

The George Washington University Biostatistics Center

People needed

11108

Starts

2010-11-01

Expected to finish

2014-08-01

Last updated by the study team

2019-07-15

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Singleton, cephalic pregnancy
• Gestational age at least 36 weeks, 1 day
• Cervical dilation of at least 2 cm and no more than 7 cm
• Ruptured membranes

You may not qualify if…

• Multifetal gestation
• Planned cesarean delivery
• Need for immediate delivery
• Absent variability or sinusoidal pattern at any time, or a Category II fetal heart rate pattern with absent variability in the last 20 minutes before randomization
• Inability to obtain or maintain an adequate signal within 3 trials of electrode placements
• Occurrence of any ST event during attempt to obtain adequate signal
• Patient pushing in the first stage of labor
• Known major fetal anomaly or fetal demise
• Previous uterine surgery
• Placenta previa on admission
• Maternal fever greater than or equal to 38 C or 100.4 F
• Active HSV infection
• Known HIV or hepatitis infection
• Other maternal and fetal contraindications for using the STAN monitor
• Enrollment in another labor study
• Participation in this trial in a previous pregnancy
• No certified or authorized provider available

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States
• Northwestern University — Chicago, Illinois, United States
• Wayne State University - Hutzel Hospital — Detroit, Michigan, United States
• Columbia University — New York, New York, United States
• University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
• Case Western University — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pittsburgh - Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
• Brown University — Providence, Rhode Island, United States
• University of Texas - Galveston — Galveston, Texas, United States
• University of Texas - Houston — Houston, Texas, United States
• University of Utah Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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