Pregnancy Clinical Trial
— STANOfficial title:
A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN)
Verified date | July 2019 |
Source | The George Washington University Biostatistics Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11108 |
Est. completion date | August 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama - Birmingham | Birmingham | Alabama |
United States | University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | Case Western University | Cleveland | Ohio |
United States | Ohio State University | Columbus | Ohio |
United States | Wayne State University - Hutzel Hospital | Detroit | Michigan |
United States | University of Texas - Galveston | Galveston | Texas |
United States | University of Texas - Houston | Houston | Texas |
United States | Columbia University | New York | New York |
United States | University of Pittsburgh - Magee Womens Hospital | Pittsburgh | Pennsylvania |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Brown University | Providence | Rhode Island |
United States | University of Utah Medical Center | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
The George Washington University Biostatistics Center | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Neoventa Medical |
United States,
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* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Number of Intrapartum Fetal Deaths (Primary Outcome Component) | Death of the fetus during the intrapartum period. | During labor and through delivery of the baby | |
Primary | Number of Neonatal Deaths (Primary Outcome Component) | Death of the newborn between delivery and1 month of age | Delivery through1 month of age | |
Primary | 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 | |
Primary | Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component) | Number of infants who experienced Neonatal Seizure | Birth through hospital discharge | |
Primary | 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 | |
Primary | Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component) | Neonatal intubation for ventilation in the delivery room | Delivery | |
Primary | Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component) | Neonatal encephalopathy experienced between delivery and discharge | Delivery through hospital discharge | |
Secondary | Number of Participants by Delivery Method | Method of delivery of the baby: spontaneous, vacuum assisted, forceps, cesarean | Delivery | |
Secondary | Number of Participants by Indication for Cesarean | indication for the cesarean delivery | At any time from randomization through delivery | |
Secondary | Number of Participants With an Indication for Forceps or Vacuum Delivery | Indication for delivery by forceps or vacuum | During labor through delivery | |
Secondary | Median Duration of Labor Post-randomization | Duration of labor in hours after randomization through delivery | Onset of Labor through delivery | |
Secondary | Number of Neonates With Shoulder Dystocia During Delivery | Presence of shoulder dystocia during delivery | Delivery | |
Secondary | Number of Participants With Chorioamnionitis | Chorioamnionitis | Any time from Randomization through Delivery | |
Secondary | Number of Participants Who Had a Postpartum Blood Transfusion | Blood transfusion from delivery and through hospital stay until discharge | Delivery through hospital discharge | |
Secondary | Number of Participants Experiencing Postpartum Endometritis | Postpartum endometritis | Delivery through hospital discharge | |
Secondary | Median Length of Hospital Stay | Days of stay in the hospital | From admission to labor and delivery through hospital discharge | |
Secondary | Number of Infants Admitted to Special Care Nursery | Intermediate care nursery or neonatal intensive care (anything more than well-baby nursery) | Delivery and 1 month of age | |
Secondary | Median Apgar Score at 5 Minutes | 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. | 5 minutes after Delivery | |
Secondary | Number of Infants With Meconium Aspiration Syndrome | Meconium aspiration syndrome | Delivery through discharge | |
Secondary | Number of Infants With a Major Congenital Malformation | Major congenital malformation | Delivery |
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