Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 11:23 PM
Study NCT ID:
NCT01131260
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2010-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fetal ST Segment and T Wave Analysis in Labor
Sponsor:
Organization:
Raw JSON
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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.'}, {'measure': 'Number of Infants With Meconium Aspiration Syndrome', 'timeFrame': 'Delivery through discharge', 'description': 'Meconium aspiration syndrome'}, {'measure': 'Number of Infants With a Major Congenital Malformation', 'timeFrame': 'Delivery', 'description': 'Major congenital malformation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['STAN', 'Fetal monitoring', 'Fetal acidosis', 'Fetal heart rate monitoring', 'Perinatology'], 'conditions': ['Pregnancy', 'Obstetric Labor', 'Parturition']}, 'referencesModule': {'references': [{'pmid': '1155132', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '7315431', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33536', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '2618763', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1940143', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7148927', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '6720798', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '2630159', 'type': 'BACKGROUND', '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. doi: 10.1088/0143-0815/10/4b/005.'}, {'pmid': '2729402', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '5372122', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11642', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1733202', 'type': 'BACKGROUND', '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. doi: 10.1016/0002-9378(92)91867-a.'}, {'pmid': '11262482', 'type': 'BACKGROUND', '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. doi: 10.1067/mob.2001.111932.'}, {'pmid': '8238177', 'type': 'BACKGROUND', '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. doi: 10.1016/0002-9378(93)90273-l.'}, {'pmid': '11520523', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16553653', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17826428', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12548215', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16855950', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12572595', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15576269', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15280112', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17368461', 'type': 'BACKGROUND', '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. doi: 10.1016/j.ijgo.2007.01.003. Epub 2007 Mar 26.'}, {'pmid': '16643829', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15280144', 'type': 'BACKGROUND', '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. doi: 10.1080/14767050410001668284.'}, {'pmid': '16949404', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18761565', 'type': 'BACKGROUND', '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.'}, {'pmid': '5581186', 'type': 'BACKGROUND', 'citation': '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. 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N Engl J Med. 2006 Nov 23;355(21):2195-202. doi: 10.1056/NEJMoa061170.'}, {'type': 'BACKGROUND', 'citation': 'Jennison C, Turnbull BW. Statistical approaches to interim monitoring of medical trials: a review and commentary. Statist. Sci. 1990; 229-317.'}, {'pmid': '3321314', 'type': 'BACKGROUND', 'citation': 'Demets DL. Practical aspects in data monitoring: a brief review. Stat Med. 1987 Oct-Nov;6(7):753-60. doi: 10.1002/sim.4780060706.'}, {'type': 'BACKGROUND', 'citation': 'Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika 1977; 64: 191-199.'}, {'pmid': '497341', 'type': 'BACKGROUND', 'citation': "O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56."}, {'type': 'BACKGROUND', 'citation': 'Lan KK, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659-63.'}, {'pmid': '3390511', 'type': 'BACKGROUND', 'citation': 'Lan KK, Wittes J. The B-value: a tool for monitoring data. Biometrics. 1988 Jun;44(2):579-85.'}, {'pmid': '1392832', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '3295858', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '2046134', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35381609', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '26267623', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.bsc.gwu.edu/mfmu', 'label': 'The public website of the NICHD Maternal Fetal Medicine Units (MFMU) Network'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN):\n\nFetal 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton, cephalic pregnancy\n* Gestational age at least 36 weeks, 1 day\n* Cervical dilation of at least 2 cm and no more than 7 cm\n* Ruptured membranes\n\nExclusion Criteria:\n\n* Multifetal gestation\n* Planned cesarean delivery\n* Need for immediate delivery\n* 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\n* Inability to obtain or maintain an adequate signal within 3 trials of electrode placements\n* Occurrence of any ST event during attempt to obtain adequate signal\n* Patient pushing in the first stage of labor\n* Known major fetal anomaly or fetal demise\n* Previous uterine surgery\n* Placenta previa on admission\n* Maternal fever greater than or equal to 38 C or 100.4 F\n* Active HSV infection\n* Known HIV or hepatitis infection\n* Other maternal and fetal contraindications for using the STAN monitor\n* Enrollment in another labor study\n* Participation in this trial in a previous pregnancy\n* No certified or authorized provider available'}, 'identificationModule': {'nctId': 'NCT01131260', 'acronym': 'STAN', 'briefTitle': 'Fetal ST Segment and T Wave Analysis in Labor', 'organization': {'class': 'OTHER', 'fullName': 'The George Washington University Biostatistics Center'}, 'officialTitle': 'A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN)', 'orgStudyIdInfo': {'id': 'HD36801-STAN'}, 'secondaryIdInfos': [{'id': 'U10HD021410', 'link': 'https://reporter.nih.gov/quickSearch/U10HD021410', 'type': 'NIH'}, {'id': 'U10HD027869', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027869', 'type': 'NIH'}, {'id': 'U10HD027917', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027917', 'type': 'NIH'}, {'id': 'U10HD053118', 'link': 'https://reporter.nih.gov/quickSearch/U10HD053118', 'type': 'NIH'}, {'id': 'U10HD027915', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027915', 'type': 'NIH'}, {'id': 'U10HD034208', 'link': 'https://reporter.nih.gov/quickSearch/U10HD034208', 'type': 'NIH'}, {'id': 'U10HD053097', 'link': 'https://reporter.nih.gov/quickSearch/U10HD053097', 'type': 'NIH'}, {'id': 'U10HD040500', 'link': 'https://reporter.nih.gov/quickSearch/U10HD040500', 'type': 'NIH'}, {'id': 'U10HD040485', 'link': 'https://reporter.nih.gov/quickSearch/U10HD040485', 'type': 'NIH'}, {'id': 'U10HD040544', 'link': 'https://reporter.nih.gov/quickSearch/U10HD040544', 'type': 'NIH'}, {'id': 'U10HD040545', 'link': 'https://reporter.nih.gov/quickSearch/U10HD040545', 'type': 'NIH'}, {'id': 'U10HD040560', 'link': 'https://reporter.nih.gov/quickSearch/U10HD040560', 'type': 'NIH'}, {'id': 'U10HD040512', 'link': 'https://reporter.nih.gov/quickSearch/U10HD040512', 'type': 'NIH'}, {'id': 'U01HD036801', 'link': 'https://reporter.nih.gov/quickSearch/U01HD036801', 'type': 'NIH'}, {'id': 'U10HD068268', 'link': 'https://reporter.nih.gov/quickSearch/U10HD068268', 'type': 'NIH'}, {'id': 'U10HD068282', 'link': 'https://reporter.nih.gov/quickSearch/U10HD068282', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Group', 'description': '• Fetal STAN monitor electrode inserted and data available to caregivers', 'interventionNames': ['Device: fetal STAN monitor']}, {'type': 'OTHER', 'label': 'Masked Group', 'description': '•Fetal STAN monitor electrode inserted, but data masked to the caregivers', 'interventionNames': ['Device: fetal STAN monitor']}], 'interventions': [{'name': 'fetal STAN monitor', 'type': 'DEVICE', 'otherNames': ['STAN S31'], 'description': '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.', 'armGroupLabels': ['Masked Group', 'Open Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35429', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama - Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University - Hutzel Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '17599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh - Magee Womens Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Menachem Miodovnik, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, {'name': 'Rebecca Clifton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Washington University Biostatistics Center'}, {'name': 'George Saade, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Texas'}, {'name': 'Michael Belfort, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Utah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The George Washington University Biostatistics Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Neoventa Medical', 'class': 'UNKNOWN'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}