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PregnancySTANNCT01131260

Fetal ST Segment and T Wave Analysis in Labor

A study testing fetal STAN monitor in people with Pregnancy and Obstetric Labor, run by The George Washington University Biostatistics Center at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Obstetric Labor, Parturition
What is being tested?
fetal STAN monitor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11,108 participants
Where
13 sitesUnited States
Study dates
Nov 2010to Aug 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35429

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 17599

  • Northwestern University

    Chicago, Illinois, 60611

  • Case Western University

    Cleveland, Ohio, 44109

  • Ohio State University

    Columbus, Ohio, 43210

  • Wayne State University - Hutzel Hospital

    Detroit, Michigan, 48201

  • University of Texas - Galveston

    Galveston, Texas, 77555

  • University of Texas - Houston

    Houston, Texas, 77030

  • Columbia University

    New York, New York, 10032

  • University of Pittsburgh - Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Brown University

    Providence, Rhode Island, 02905

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
fetal STAN monitor
Keywords
STAN, Fetal monitoring, Fetal acidosis, Fetal heart rate monitoring, Perinatology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fetal STAN monitorDevice

    Also called STAN S31

    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.

Study groups in NCT01131260
Study groupRoleWhat they receive
Open GroupExperimental• Fetal STAN monitor electrode inserted and data available to caregivers
Receives: Device: fetal STAN monitor
Masked GroupOther•Fetal STAN monitor electrode inserted, but data masked to the caregivers
Receives: Device: fetal STAN monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From Delivery through 1 month of age

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

    Death of the fetus during the intrapartum period.

    Measured: During labor and through delivery of the baby

  3. Number of Neonatal Deaths (Primary Outcome Component)

    Death of the newborn between delivery and1 month of age

    Measured: Delivery through1 month of age

  4. 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.

    Measured: 5 minutes after delivery

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

    Number of infants who experienced Neonatal Seizure

    Measured: Birth through hospital discharge

  6. 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

    Measured: Delivery

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

    Neonatal intubation for ventilation in the delivery room

    Measured: Delivery

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

    Neonatal encephalopathy experienced between delivery and discharge

    Measured: Delivery through hospital discharge

Secondary outcomes (13)

  1. Number of Participants by Delivery Method

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

    Measured: Delivery

  2. Number of Participants by Indication for Cesarean

    indication for the cesarean delivery

    Measured: At any time from randomization through delivery

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

    Indication for delivery by forceps or vacuum

    Measured: During labor through delivery

  4. Median Duration of Labor Post-randomization

    Duration of labor in hours after randomization through delivery

    Measured: Onset of Labor through delivery

  5. Number of Neonates With Shoulder Dystocia During Delivery

    Presence of shoulder dystocia during delivery

    Measured: Delivery

  6. Number of Participants With Chorioamnionitis

    Chorioamnionitis

    Measured: Any time from Randomization through Delivery

  7. Number of Participants Who Had a Postpartum Blood Transfusion

    Blood transfusion from delivery and through hospital stay until discharge

    Measured: Delivery through hospital discharge

  8. Number of Participants Experiencing Postpartum Endometritis

    Postpartum endometritis

    Measured: Delivery through hospital discharge

  9. Median Length of Hospital Stay

    Days of stay in the hospital

    Measured: From admission to labor and delivery through hospital discharge

  10. Number of Infants Admitted to Special Care Nursery

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

    Measured: Delivery and 1 month of age

  11. 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.

    Measured: 5 minutes after Delivery

  12. Number of Infants With Meconium Aspiration Syndrome

    Meconium aspiration syndrome

    Measured: Delivery through discharge

  13. Number of Infants With a Major Congenital Malformation

    Major congenital malformation

    Measured: Delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionApr 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Masking
Single blind
Who is masked
Care provider
Enrolment
11,108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01131260
Sponsor's protocol ID
HD36801-STAN
Other IDs
U10HD021410, U10HD027869, U10HD027917, U10HD053118, U10HD027915, U10HD034208, U10HD053097, U10HD040500
Acronym
STAN
Status last verified
Jul 2019
First submitted
25 May 2010
Last updated
15 Jul 2019
Data monitoring committee
Yes
Individual data sharing
Yes: The dataset will be shared per NIH policy after the completion and publication of the main analyses. Requests for datasets can be sent to mfmudatasets@bsc.gwu.edu

Publications

  • Rosen KG, Kjellmer I. Changes in the fetal heart rate and ECG during hypoxia. Acta Physiol Scand. 1975 Jan;93(1):59-66. doi: 10.1111/j.1748-1716.1975.tb05790.x.

    PubMed 1155132

  • Rosen KG, Isaksson O. Alterations in the fetal heart rate and ECG correlated to glycogen, creatine phosphate and ATP levels during graded hypoxia. Biol Neonate 1976;30:17-24

  • Hokegard KH, Eriksson BO, Kjellmer I, Magno R, Rosen KG. Myocardial metabolism in relation to electrocardiographic changes and cardiac function during graded hypoxia in the fetal lamb. Acta Physiol Scand. 1981 Sep;113(1):1-7. doi: 10.1111/j.1748-1716.1981.tb06853.x.

    PubMed 7315431

  • Hokegard KH, Karlsson K, Kjellmer I, Rosen KG. ECG-changes in the fetal lamb during asphyxia in relation to beta-adrenoceptor stimulation and blockade. Acta Physiol Scand. 1979 Feb;105(2):195-203. doi: 10.1111/j.1748-1716.1979.tb06331.x.

    PubMed 33536

  • Dagbjartsson A, Herbertsson G, Stefansson TS, Kjeld M, Lagercrantz H, Rosen KG. Beta-adrenoceptor agonists and hypoxia in sheep fetuses. Acta Physiol Scand. 1989 Oct;137(2):291-9. doi: 10.1111/j.1748-1716.1989.tb08750.x.

    PubMed 2618763

  • Widmark C, Jansson T, Lindecrantz K, Rosen KG. ECG waveform, short term heart rate variability and plasma catecholamine concentrations in response to hypoxia in intrauterine growth retarded guinea-pig fetuses. J Dev Physiol. 1991 Mar;15(3):161-8.

    PubMed 1940143

  • Greene KR, Dawes GS, Lilja H, Rosen KG. Changes in the ST waveform of the fetal lamb electrocardiogram with hypoxemia. Am J Obstet Gynecol. 1982 Dec 15;144(8):950-8. doi: 10.1016/0002-9378(82)90190-9.

    PubMed 7148927

  • Rosen KG, Dagbjartsson A, Henriksson BA, Lagercrantz H, Kjellmer I. The relationship between circulating catecholamines and ST waveform in the fetal lamb electrocardiogram during hypoxia. Am J Obstet Gynecol. 1984 May 15;149(2):190-5. doi: 10.1016/0002-9378(84)90197-2.

    PubMed 6720798

  • Greene KR, Rosen KG. Long-term ST waveform changes in the ovine fetal electrocardiogram: the relationship to spontaneous labour and intrauterine death. Clin Phys Physiol Meas. 1989;10 Suppl B:33-40. doi: 10.1088/0143-0815/10/4b/005.

    PubMed 2630159

  • Widmark C, Hokegard KH, Lagercrantz H, Lilja H, Rosen KG. Electrocardiographic waveform changes and catecholamine responses during acute hypoxia in the immature and mature fetal lamb. Am J Obstet Gynecol. 1989 May;160(5 Pt 1):1245-50. doi: 10.1016/0002-9378(89)90204-4.

    PubMed 2729402

  • Gelli MG, Bergstrom J, Hultman E, Thalme B. Heart muscle and plasma electrolytes in normal and glucose-loaded rabbit foetuses under anoxia. Acta Obstet Gynecol Scand. 1969;48(1):34-55. doi: 10.3109/00016346909156625. No abstract available.

    PubMed 5372122

  • Rosen KG, Hokegard KH, Kjellmer I. A study of the relationship between the electrocardiogram and hemodynamics in the fetal lamb during asphyxia. Acta Physiol Scand. 1976 Nov;98(3):275-84. doi: 10.1111/j.1748-1716.1976.tb10312.x.

    PubMed 11642

  • Watanabe T, Okamura K, Tanigawara S, Shintaku Y, Akagi K, Endo H, Yajima A. Change in electrocardiogram T-wave amplitude during umbilical cord compression is predictive of fetal condition in sheep. Am J Obstet Gynecol. 1992 Jan;166(1 Pt 1):246-55. doi: 10.1016/0002-9378(92)91867-a.

    PubMed 1733202

  • Westgate JA, Bennet L, Brabyn C, Williams CE, Gunn AJ. ST waveform changes during repeated umbilical cord occlusions in near-term fetal sheep. Am J Obstet Gynecol. 2001 Mar;184(4):743-51. doi: 10.1067/mob.2001.111932.

    PubMed 11262482

  • Westgate J, Harris M, Curnow JS, Greene KR. Plymouth randomized trial of cardiotocogram only versus ST waveform plus cardiotocogram for intrapartum monitoring in 2400 cases. Am J Obstet Gynecol. 1993 Nov;169(5):1151-60. doi: 10.1016/0002-9378(93)90273-l.

    PubMed 8238177

Questions about this trial

What is this clinical trial studying?

A study testing fetal STAN monitor in people with Pregnancy and Obstetric Labor, run by The George Washington University Biostatistics Center at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Primary Composite Outcome (time frame: From Delivery through 1 month of age). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01131260, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.

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