Fetal ST Segment and T Wave Analysis in Labor

Pregnancy Clinical Trial

— STAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131260
• Other study ID #: HD36801-STAN
• Secondary ID: U10HD021410U10HD
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: August 2014

Study information

• Verified date: July 2019
• Source: The George Washington University Biostatistics Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Obstetric Labor
• Parturition
• Pregnancy

Intervention

Device:
• fetal STAN monitor
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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
The George Washington University Biostatistics Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Neoventa Medical

Country where clinical trial is conducted

United States, 

References & Publications (40)

Amer-Wåhlin I, Bördahl P, Eikeland T, Hellsten C, Norén H, Sörnes T, Rosén KG. ST analysis of the fetal electrocardiogram during labor: Nordic observational multicenter study. J Matern Fetal Neonatal Med. 2002 Oct;12(4):260-6. — View Citation

Amer-Wåhlin I, Hellsten C, Norén H, Hagberg H, Herbst A, Kjellmer I, Lilja H, Lindoff C, Månsson M, Mårtensson L, Olofsson P, Sundström A, Marsál K. Cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram for intrapartum fetal monitoring: a Swedish randomised controlled trial. Lancet. 2001 Aug 18;358(9281):534-8. — View Citation

Bloom SL, Spong CY, Thom E, Varner MW, Rouse DJ, Weininger S, Ramin SM, Caritis SN, Peaceman A, Sorokin Y, Sciscione A, Carpenter M, Mercer B, Thorp J, Malone F, Harper M, Iams J, Anderson G; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Fetal pulse oximetry and cesarean delivery. N Engl J Med. 2006 Nov 23;355(21):2195-202. — View Citation

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Devoe LD, Ross M, Wilde C, Beal M, Lysikewicz A, Maier J, Vines V, Amer-Wåhlin I, Lilja H, Norén H, Maulik D. United States multicenter clinical usage study of the STAN 21 electronic fetal monitoring system. Am J Obstet Gynecol. 2006 Sep;195(3):729-34. — View Citation

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Greene KR, Dawes GS, Lilja H, Rosén KG. Changes in the ST waveform of the fetal lamb electrocardiogram with hypoxemia. Am J Obstet Gynecol. 1982 Dec 15;144(8):950-8. — View Citation

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. — View Citation

Hökegård KH, Eriksson BO, Kjellmer I, Magno R, Rosén 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. — View Citation

Hökegård KH, Karlsson K, Kjellmer I, Rosén 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. — View Citation

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Kwee A, van der Hoorn-van den Beld CW, Veerman J, Dekkers AH, Visser GH. STAN S21 fetal heart monitor for fetal surveillance during labor: an observational study in 637 patients. J Matern Fetal Neonatal Med. 2004 Jun;15(6):400-7. — View Citation

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Lan KK, Wittes J. The B-value: a tool for monitoring data. Biometrics. 1988 Jun;44(2):579-85. — View Citation

Luttkus AK, Norén H, Stupin JH, Blad S, Arulkumaran S, Erkkola R, Hagberg H, Lenstrup C, Visser GH, Tamazian O, Yli B, Rosén KG, Dudenhausen JW. Fetal scalp pH and ST analysis of the fetal ECG as an adjunct to CTG. A multi-center, observational study. J Perinat Med. 2004;32(6):486-94. — View Citation

Macones GA, Hankins GD, Spong CY, Hauth J, Moore T. The 2008 National Institute of Child Health and Human Development workshop report on electronic fetal monitoring: update on definitions, interpretation, and research guidelines. J Obstet Gynecol Neonatal Nurs. 2008 Sep-Oct;37(5):510-5. doi: 10.1111/j.1552-6909.2008.00284.x. — View Citation

Neilson JP. Fetal electrocardiogram (ECG) for fetal monitoring during labour. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD000116. Review. Update in: Cochrane Database Syst Rev. 2012;4:CD000116. — View Citation

Norén H, Amer-Wåhlin I, Hagberg H, Herbst A, Kjellmer I, Marsál K, Olofsson P, Rosén KG. Fetal electrocardiography in labor and neonatal outcome: data from the Swedish randomized controlled trial on intrapartum fetal monitoring. Am J Obstet Gynecol. 2003 Jan;188(1):183-92. — View Citation

Norén H, Blad S, Carlsson A, Flisberg A, Gustavsson A, Lilja H, Wennergren M, Hagberg H. STAN in clinical practice--the outcome of 2 years of regular use in the city of Gothenburg. Am J Obstet Gynecol. 2006 Jul;195(1):7-15. Epub 2006 Apr 27. — View Citation

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Ojala K, Vääräsmäki M, Mäkikallio K, Valkama M, Tekay A. A comparison of intrapartum automated fetal electrocardiography and conventional cardiotocography--a randomised controlled study. BJOG. 2006 Apr;113(4):419-23. — View Citation

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Pocock SJ. When to stop a clinical trial. BMJ. 1992 Jul 25;305(6847):235-40. — View Citation

Rosén 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. — View Citation

Rosén KG, Hökegård 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. — View Citation

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Rosén KG, Kjellmer I. Changes in the fetal heart rate and ECG during hypoxia. Acta Physiol Scand. 1975 Jan;93(1):59-66. — View Citation

Ross MG, Devoe LD, Rosen KG. ST-segment analysis of the fetal electrocardiogram improves fetal heart rate tracing interpretation and clinical decision making. J Matern Fetal Neonatal Med. 2004 Mar;15(3):181-5. — View Citation

Shankaran S, Laptook AR, Ehrenkranz RA, Tyson JE, McDonald SA, Donovan EF, Fanaroff AA, Poole WK, Wright LL, Higgins RD, Finer NN, Carlo WA, Duara S, Oh W, Cotten CM, Stevenson DK, Stoll BJ, Lemons JA, Guillet R, Jobe AH; National Institute of Child Health and Human Development Neonatal Research Network. Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med. 2005 Oct 13;353(15):1574-84. — View Citation

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Vayssière C, David E, Meyer N, Haberstich R, Sebahoun V, Roth E, Favre R, Nisand I, Langer B. A French randomized controlled trial of ST-segment analysis in a population with abnormal cardiotocograms during labor. Am J Obstet Gynecol. 2007 Sep;197(3):299.e1-6. — View Citation

Vayssiere C, Haberstich R, Sebahoun V, David E, Roth E, Langer B. Fetal electrocardiogram ST-segment analysis and prediction of neonatal acidosis. Int J Gynaecol Obstet. 2007 May;97(2):110-4. Epub 2007 Mar 26. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Widmark C, Hökegård KH, Lagercrantz H, Lilja H, Rosén 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. — View Citation

Widmark C, Jansson T, Lindecrantz K, Rosén 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. — View Citation

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* Note: There are 40 references in all — Click here to view all references

Outcome

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

External Links

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