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Completed

NCT Number: NCT01131260

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.

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Key information

Conditions

Pregnancy Obstetric Labor Parturition

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama - Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fetal STAN monitor

Device

The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG.

Other names: STAN S31

Primary outcomes

  1. Number of Participants With Primary Composite Outcome

    Time frame: From Delivery through 1 month of age

    Composite primary outcome of intrapartum fetal death, neonatal death, Apgar score <=3 at 5 minutes, neonatal seizure, umbilical artery blood pH <= 7.05 with base deficit >=12 mmol/L in extra-cellular fluid, intubation for ventilation at delivery, neonatal encelphalopathy

  2. Number of Intrapartum Fetal Deaths (Primary Outcome Component)

    Time frame: During labor and through delivery of the baby

    Death of the fetus during the intrapartum period.

  3. Number of Neonatal Deaths (Primary Outcome Component)

    Time frame: Delivery through1 month of age

    Death of the newborn between delivery and1 month of age

  4. Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component)

    Time frame: 5 minutes after delivery

    The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score. The lowest score is 0, the highest score is 10.

  5. Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component)

    Time frame: Birth through hospital discharge

    Number of infants who experienced Neonatal Seizure

  6. Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component)

    Time frame: Delivery

    Umbilical-artery blood pH < = 7.05 and base deficit in extracellular fluid > = 12 mmol/liter

  7. Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component)

    Time frame: Delivery

    Neonatal intubation for ventilation in the delivery room

  8. Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component)

    Time frame: Delivery through hospital discharge

    Neonatal encephalopathy experienced between delivery and discharge

Secondary outcomes

  1. Number of Participants by Delivery Method

    Time frame: Delivery

    Method of delivery of the baby: spontaneous, vacuum assisted, forceps, cesarean

  2. Number of Participants by Indication for Cesarean

    Time frame: At any time from randomization through delivery

    indication for the cesarean delivery

  3. Number of Participants With an Indication for Forceps or Vacuum Delivery

    Time frame: During labor through delivery

    Indication for delivery by forceps or vacuum

  4. Median Duration of Labor Post-randomization

    Time frame: Onset of Labor through delivery

    Duration of labor in hours after randomization through delivery

  5. Number of Neonates With Shoulder Dystocia During Delivery

    Time frame: Delivery

    Presence of shoulder dystocia during delivery

  6. Number of Participants With Chorioamnionitis

    Time frame: Any time from Randomization through Delivery

    Chorioamnionitis

  7. Number of Participants Who Had a Postpartum Blood Transfusion

    Time frame: Delivery through hospital discharge

    Blood transfusion from delivery and through hospital stay until discharge

  8. Number of Participants Experiencing Postpartum Endometritis

    Time frame: Delivery through hospital discharge

    Postpartum endometritis

  9. Median Length of Hospital Stay

    Time frame: From admission to labor and delivery through hospital discharge

    Days of stay in the hospital

  10. Number of Infants Admitted to Special Care Nursery

    Time frame: Delivery and 1 month of age

    Intermediate care nursery or neonatal intensive care (anything more than well-baby nursery)

  11. Median Apgar Score at 5 Minutes

    Time frame: 5 minutes after Delivery

    The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score.

  12. Number of Infants With Meconium Aspiration Syndrome

    Time frame: Delivery through discharge

    Meconium aspiration syndrome

  13. Number of Infants With a Major Congenital Malformation

    Time frame: Delivery

    Major congenital malformation

Sponsors and collaborators

Lead sponsor

The George Washington University Biostatistics Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Neoventa Medical

Registry information

Official study title

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

Acronym: STAN

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 26, 2010
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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