Clinical trial NCT01131260: Fetal ST Segment and T Wave Analysis in Labor
Official title: A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Obstetric Labor
Parturition
Keywords: STAN
Fetal monitoring
Fetal acidosis
Fetal heart rate monitoring
Perinatology
Lead sponsor: The George Washington University Biostatistics Center
Sponsor class: OTHER
Collaborators: name: Neoventa Medical
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-05-26
Enrollment: 11108
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized, controlled clinical trial of 11,000 women in labor at \> 36.0 weeks gestation randomized to one of two groups using the STAN S31 system:

* Fetal STAN electrode inserted and data available to caregivers (open device group)
* Fetal STAN electrode inserted, but data masked to the caregivers (masked device group)
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Primary Composite Outcome
timeFrame: From Delivery through 1 month of age
measure: Number of Intrapartum Fetal Deaths (Primary Outcome Component)
timeFrame: During labor and through delivery of the baby
measure: Number of Neonatal Deaths (Primary Outcome Component)
timeFrame: Delivery through1 month of age
measure: Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component)
timeFrame: 5 minutes after delivery
measure: Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component)
timeFrame: Birth through hospital discharge
measure: Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component)
timeFrame: Delivery
measure: Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component)
timeFrame: Delivery
measure: Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component)
timeFrame: Delivery through hospital discharge
Secondary outcomes:
measure: Number of Participants by Delivery Method
timeFrame: Delivery
measure: Number of Participants by Indication for Cesarean
timeFrame: At any time from randomization through delivery
measure: Number of Participants With an Indication for Forceps or Vacuum Delivery
timeFrame: During labor through delivery
measure: Median Duration of Labor Post-randomization
timeFrame: Onset of Labor through delivery
measure: Number of Neonates With Shoulder Dystocia During Delivery
timeFrame: Delivery
measure: Number of Participants With Chorioamnionitis
timeFrame: Any time from Randomization through Delivery
measure: Number of Participants Who Had a Postpartum Blood Transfusion
timeFrame: Delivery through hospital discharge
measure: Number of Participants Experiencing Postpartum Endometritis
timeFrame: Delivery through hospital discharge
measure: Median Length of Hospital Stay
timeFrame: From admission to labor and delivery through hospital discharge
measure: Number of Infants Admitted to Special Care Nursery
timeFrame: Delivery and 1 month of age
measure: Median Apgar Score at 5 Minutes
timeFrame: 5 minutes after Delivery
measure: Number of Infants With Meconium Aspiration Syndrome
timeFrame: Delivery through discharge
measure: Number of Infants With a Major Congenital Malformation
timeFrame: Delivery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham
state: Alabama
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Detroit
country: United States
facility: Wayne State University - Hutzel Hospital
state: Michigan
city: New York
country: United States
facility: Columbia University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: Case Western University
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh - Magee Womens Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Brown University
state: Rhode Island
city: Galveston
country: United States
facility: University of Texas - Galveston
state: Texas
city: Houston
country: United States
facility: University of Texas - Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Medical Center
state: Utah
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Menachem Miodovnik, MD
role: STUDY_DIRECTOR
affiliation: George Washington University Biostatistics Center
name: Rebecca Clifton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: George Saade, MD
role: STUDY_CHAIR
affiliation: University of Utah
name: Michael Belfort, MD
role: STUDY_CHAIR
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