Trial Search Results

Fetal ST Segment and T Wave Analysis in Labor

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

The George Washington University Biostatistics Center

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

Stanford Investigator(s):

Intervention(s):

  • Device: fetal STAN monitor

Phase:

N/A

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

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

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