Fetal ST Segment and T Wave Analysis in Labor

NCT01131260 | Completed Results DMC

• 17 other identifiers: HD36801-STANU10HD021410U10HD027869U10HD027917U10HD053118U10HD027915U10HD034208U10HD053097U10HD040500U10HD040485U10HD040544U10HD040545U10HD040560U10HD040512U01HD036801U10HD068268U10HD068282
• Study Type: interventional
• Target: 11,108
• Locations: 1 country
• Sites: 13

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.

Conditions

Pregnancy; Obstetric Labor; Parturition

Keywords

STAN; Fetal monitoring; Fetal acidosis; Fetal heart rate monitoring; Perinatology

Outcome Measures

Primary Outcomes (8)

• Number of Participants With Primary Composite Outcome

  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

  From Delivery through 1 month of age

• Number of Intrapartum Fetal Deaths (Primary Outcome Component)

  Death of the fetus during the intrapartum period.

  During labor and through delivery of the baby

• Number of Neonatal Deaths (Primary Outcome Component)

  Death of the newborn between delivery and1 month of age

  Delivery through1 month of age

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

  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 minutes after delivery

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

  Number of infants who experienced Neonatal Seizure

  Birth through hospital discharge

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

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

  Delivery

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

  Neonatal intubation for ventilation in the delivery room

  Delivery

• Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component)

  Neonatal encephalopathy experienced between delivery and discharge

  Delivery through hospital discharge

Secondary Outcomes (13)

• Number of Participants by Delivery Method

  Delivery

• Number of Participants by Indication for Cesarean

  At any time from randomization through delivery

• Number of Participants With an Indication for Forceps or Vacuum Delivery

  During labor through delivery

• Median Duration of Labor Post-randomization

  Onset of Labor through delivery

• Number of Neonates With Shoulder Dystocia During Delivery

  Delivery

Study Arms (2)

Open Group

EXPERIMENTAL

• Fetal STAN monitor electrode inserted and data available to caregivers

Device: fetal STAN monitor

Masked Group

OTHER

•Fetal STAN monitor electrode inserted, but data masked to the caregivers

Device: fetal STAN monitor

Interventions

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.

Also known as: STAN S31

Masked Group; Open Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The George Washington University Biostatistics Center: lead
• Neoventa Medical: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (13)

University of Alabama - Birmingham

Birmingham, Alabama, 35429, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Wayne State University - Hutzel Hospital

Detroit, Michigan, 48201, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 17599, United States

Location

Case Western University

Cleveland, Ohio, 44109, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pittsburgh - Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Brown University

Providence, Rhode Island, 02905, United States

Location

University of Texas - Galveston

Galveston, Texas, 77555, United States

Location

University of Texas - Houston

Houston, Texas, 77030, United States

Location

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (42)

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Related Links

• The public website of the NICHD Maternal Fetal Medicine Units (MFMU) Network

Results Point of Contact

• Title: Rebecca Clifton, Ph.D.
• Organization: The George Washington University Biostatistics Center

rclifton@bsc.gwu.edu

301-881-9260

Study Officials

• Menachem Miodovnik, MD

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

  STUDY DIRECTOR

• Rebecca Clifton, PhD

  George Washington University Biostatistics Center

  PRINCIPAL INVESTIGATOR

• George Saade, MD

  University of Texas

  STUDY CHAIR

• Michael Belfort, MD

  University of Utah

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: May 26, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 15, 2019
• Results First Posted: April 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

US (13)