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Fetal ST Segment and T Wave A...

Fetal ST Segment and T Wave Analysis in Labor

Last Updated: 2019-07-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

11108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pregnancy Obstetric Labor Parturition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Open Group

• Fetal STAN monitor electrode inserted and data available to caregivers

Group Type EXPERIMENTAL

fetal STAN monitor

Intervention Type 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.

Masked Group

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

Group Type OTHER

fetal STAN monitor

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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STAN S31

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Menachem Miodovnik, MD

Role: STUDY_DIRECTOR

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

Rebecca Clifton, PhD

Role: PRINCIPAL_INVESTIGATOR

George Washington University Biostatistics Center

George Saade, MD

Role: STUDY_CHAIR

University of Texas

Michael Belfort, MD

Role: STUDY_CHAIR

University of Utah

Locations

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University of Alabama - Birmingham

Birmingham, Alabama, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Wayne State University - Hutzel Hospital

Detroit, Michigan, United States

Site Status

Columbia University

New York, New York, United States

Site Status

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Case Western University

Cleveland, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

University of Pittsburgh - Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Brown University

Providence, Rhode Island, United States

Site Status

University of Texas - Galveston

Galveston, Texas, United States

Site Status

University of Texas - Houston

Houston, Texas, United States

Site Status

University of Utah Medical Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 1155132 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

PMID: 7315431 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 33536 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 2618763 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 1940143 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 7148927 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 6720798 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 2630159 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 2729402 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 5372122 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11642 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 1733202 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11262482 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 8238177 (View on PubMed)

Amer-Wahlin I, Hellsten C, Noren H, Hagberg H, Herbst A, Kjellmer I, Lilja H, Lindoff C, Mansson M, Martensson L, Olofsson P, Sundstrom A, Marsal 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. doi: 10.1016/s0140-6736(01)05703-8.

Reference Type BACKGROUND

PMID: 11520523 (View on PubMed)

Ojala K, Vaarasmaki M, Makikallio 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. doi: 10.1111/j.1471-0528.2006.00886.x.

Reference Type BACKGROUND

PMID: 16553653 (View on PubMed)

Vayssiere 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. doi: 10.1016/j.ajog.2007.07.007.

Reference Type BACKGROUND

PMID: 17826428 (View on PubMed)

Noren H, Amer-Wahlin I, Hagberg H, Herbst A, Kjellmer I, Marsal K, Olofsson P, Rosen 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. doi: 10.1067/mob.2003.109.

Reference Type BACKGROUND

PMID: 12548215 (View on PubMed)

Neilson JP. Fetal electrocardiogram (ECG) for fetal monitoring during labour. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD000116. doi: 10.1002/14651858.CD000116.pub2.

Reference Type BACKGROUND

PMID: 16855950 (View on PubMed)

Amer-Wahlin I, Bordahl P, Eikeland T, Hellsten C, Noren H, Sornes T, Rosen KG. ST analysis of the fetal electrocardiogram during labor: Nordic observational multicenter study. J Matern Fetal Neonatal Med. 2002 Oct;12(4):260-6. doi: 10.1080/jmf.12.4.260.266.

Reference Type BACKGROUND

PMID: 12572595 (View on PubMed)

Luttkus AK, Noren H, Stupin JH, Blad S, Arulkumaran S, Erkkola R, Hagberg H, Lenstrup C, Visser GH, Tamazian O, Yli B, Rosen 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. doi: 10.1515/JPM.2004.121.

Reference Type BACKGROUND

PMID: 15576269 (View on PubMed)

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. doi: 10.1080/14767050410001727404.

Reference Type BACKGROUND

PMID: 15280112 (View on PubMed)

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. doi: 10.1016/j.ijgo.2007.01.003. Epub 2007 Mar 26.

Reference Type BACKGROUND

PMID: 17368461 (View on PubMed)

Noren 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. doi: 10.1016/j.ajog.2006.01.108. Epub 2006 Apr 27.

Reference Type BACKGROUND

PMID: 16643829 (View on PubMed)

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. doi: 10.1080/14767050410001668284.

Reference Type BACKGROUND

PMID: 15280144 (View on PubMed)

Devoe LD, Ross M, Wilde C, Beal M, Lysikewicz A, Maier J, Vines V, Amer-Wahlin I, Lilja H, Noren 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. doi: 10.1016/j.ajog.2006.06.002.

Reference Type BACKGROUND

PMID: 16949404 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 18761565 (View on PubMed)

Siggaard-Andersen O. An acid-base chart for arterial blood with normal and pathophysiological reference areas. Scand J Clin Lab Invest. 1971 May;27(3):239-45. doi: 10.3109/00365517109080214. No abstract available.

Reference Type BACKGROUND

PMID: 5581186 (View on PubMed)

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. doi: 10.1056/NEJMcps050929.

Reference Type BACKGROUND

PMID: 16221780 (View on PubMed)

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. doi: 10.1056/NEJMoa061170.

Reference Type BACKGROUND

PMID: 17124017 (View on PubMed)

Jennison C, Turnbull BW. Statistical approaches to interim monitoring of medical trials: a review and commentary. Statist. Sci. 1990; 229-317.

Reference Type BACKGROUND

Demets DL. Practical aspects in data monitoring: a brief review. Stat Med. 1987 Oct-Nov;6(7):753-60. doi: 10.1002/sim.4780060706.

Reference Type BACKGROUND

PMID: 3321314 (View on PubMed)

Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika 1977; 64: 191-199.

Reference Type BACKGROUND

O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.

Reference Type BACKGROUND

PMID: 497341 (View on PubMed)

Lan KK, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659-63.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

PMID: 3390511 (View on PubMed)

Pocock SJ. When to stop a clinical trial. BMJ. 1992 Jul 25;305(6847):235-40. doi: 10.1136/bmj.305.6847.235. No abstract available.

Reference Type BACKGROUND

PMID: 1392832 (View on PubMed)

Stallones RA. The use and abuse of subgroup analysis in epidemiological research. Prev Med. 1987 Mar;16(2):183-94. doi: 10.1016/0091-7435(87)90082-x.

Reference Type BACKGROUND

PMID: 3295858 (View on PubMed)

Yusuf S, Wittes J, Probstfield J, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA. 1991 Jul 3;266(1):93-8.

Reference Type BACKGROUND

PMID: 2046134 (View on PubMed)

Plunkett BA, Weiner SJ, Saade GR, Belfort MA, Blackwell SC, Thorp JM Jr, Tita ATN, Miller RS, McKenna DS, Chien EKS, Rouse DJ, El-Sayed YY, Sorokin Y, Caritis SN; Eunice Kennedy Shriver National Institute of Child Health Human Development Maternal-Fetal Medicine Units (MFMU) Network*. Maternal Diabetes and Intrapartum Fetal Electrocardiogram. Am J Perinatol. 2024 May;41(S 01):e14-e21. doi: 10.1055/a-1817-5788. Epub 2022 Apr 5.

Reference Type DERIVED

PMID: 35381609 (View on PubMed)

Belfort MA, Saade GR, Thom E, Blackwell SC, Reddy UM, Thorp JM Jr, Tita AT, Miller RS, Peaceman AM, McKenna DS, Chien EK, Rouse DJ, Gibbs RS, El-Sayed YY, Sorokin Y, Caritis SN, VanDorsten JP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis. N Engl J Med. 2015 Aug 13;373(7):632-41. doi: 10.1056/NEJMoa1500600.

Reference Type DERIVED

PMID: 26267623 (View on PubMed)