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Fetal ST Segment and T Wave Analysis in Labor

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Trial ID: NCT01131260

Age - N/A-N/A Condition - Obstetrics, Maternal and Fetal Medicine Gender - Female Accepting Healthy Volunteers - yes

Purpose

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.

Official Title

A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN)

Stanford Investigator(s)

Yasser El-Sayed, Professor
Yasser El-Sayed, Professor

Charles B. and Ann L. Johnson Professor in the School of Medicine and Professor, by courtesy, of Pediatrics (Neonatology) and of Surgery

Eligibility


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - 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

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Intervention(s):

device: fetal STAN monitor

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Dr. Yasser El-Sayed
650 725-8623

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