Fetal ST Segment and T Wave Analysis in Labor (STAN)

The George Washington University Biostatistics Center

Status

Completed

Conditions

Parturition

Obstetric Labor

Pregnancy

Treatments

Device: fetal STAN monitor

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01131260

U10HD053097 (U.S. NIH Grant/Contract)

U10HD040544 (U.S. NIH Grant/Contract)

U10HD053118 (U.S. NIH Grant/Contract)

U10HD068268 (U.S. NIH Grant/Contract)

U10HD040545 (U.S. NIH Grant/Contract)

U01HD036801 (U.S. NIH Grant/Contract)

U10HD040500 (U.S. NIH Grant/Contract)

U10HD068282 (U.S. NIH Grant/Contract)

U10HD027915 (U.S. NIH Grant/Contract)

U10HD027917 (U.S. NIH Grant/Contract)

U10HD027869 (U.S. NIH Grant/Contract)

U10HD034208 (U.S. NIH Grant/Contract)

U10HD040560 (U.S. NIH Grant/Contract)

HD36801-STAN

U10HD040512 (U.S. NIH Grant/Contract)

U10HD040485 (U.S. NIH Grant/Contract)

U10HD021410 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Fetal ECG analysis of the ST segment (STAN) is now FDA-approved and clinically available in the United States as an adjunct for the interpretation of electronic fetal heart rate patterns. There have been a number of randomized controlled trials as well as observational studies in Europe documenting utility of this modality in terms of reducing fetal acidosis at birth, and decreasing the need for operative vaginal delivery. However, despite these endorsements, there remain concerns with the application of the technology to the United States. None of the randomized trials were performed in the United States where patient case-mix and obstetrical practice, such as the use of fetal scalp pH, differ from Europe, which may affect the impact of this technology on perinatal outcomes. Moreover, the results of the European studies are not uniformly positive.

This protocol describes a randomized controlled trial of the STAN technology as an adjunct to electronic fetal heart rate monitoring versus fetal heart rate monitoring alone.

Enrollment

11,108 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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