Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-22 @ 5:15 PM
Study NCT ID:
NCT01367132
Status:
COMPLETED
Last Update Posted:
2013-02-22
First Post:
2011-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-20', 'studyFirstSubmitDate': '2011-06-01', 'studyFirstSubmitQcDate': '2011-06-03', 'lastUpdatePostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of the number of vessels in the umbilical cord between 11 and 13 6/7 weeks.', 'timeFrame': '11-13+6 weeks'}, {'measure': 'Detection of the number of vessels in the umbilical cord between 18 and 23 6/7 weeks.', 'timeFrame': '18 - 23 6/7 weeks'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord between 11 and 13 6/7 weeks.', 'timeFrame': '11-13+6 weeks gestational age'}, {'measure': 'Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord during the second trimester.', 'timeFrame': '18-24 weeks gestation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ultrasound', 'first trimester', 'umbilical cord'], 'conditions': ['Umbilical Cord']}, 'referencesModule': {'references': [{'pmid': '1827525', 'type': 'BACKGROUND', 'citation': "Cuckle H, Nanchahal K, Wald N. Birth prevalence of Down's syndrome in England and Wales. Prenat Diagn. 1991 Jan;11(1):29-34. doi: 10.1002/pd.1970110106."}, {'pmid': '17197615', 'type': 'BACKGROUND', 'citation': 'ACOG Committee on Practice Bulletins. ACOG Practice Bulletin No. 77: screening for fetal chromosomal abnormalities. Obstet Gynecol. 2007 Jan;109(1):217-27. doi: 10.1097/00006250-200701000-00054.'}, {'pmid': '9476332', 'type': 'BACKGROUND', 'citation': 'Souka AP, Nicolaides KH. Diagnosis of fetal abnormalities at the 10-14-week scan. Ultrasound Obstet Gynecol. 1997 Dec;10(6):429-42. doi: 10.1046/j.1469-0705.1997.10060429.x. No abstract available.'}, {'pmid': '11981912', 'type': 'BACKGROUND', 'citation': 'Dugoff L. Ultrasound diagnosis of structural abnormalities in the first trimester. Prenat Diagn. 2002 Apr;22(4):316-20. doi: 10.1002/pd.309.'}, {'pmid': '10492104', 'type': 'BACKGROUND', 'citation': 'Whitlow BJ, Chatzipapas IK, Lazanakis ML, Kadir RA, Economides DL. The value of sonography in early pregnancy for the detection of fetal abnormalities in an unselected population. Br J Obstet Gynaecol. 1999 Sep;106(9):929-36. doi: 10.1111/j.1471-0528.1999.tb08432.x.'}, {'pmid': '10426606', 'type': 'BACKGROUND', 'citation': 'Economides DL, Whitlow BJ, Braithwaite JM. Ultrasonography in the detection of fetal anomalies in early pregnancy. Br J Obstet Gynaecol. 1999 Jun;106(6):516-23. doi: 10.1111/j.1471-0528.1999.tb08317.x. No abstract available.'}, {'pmid': '16570262', 'type': 'BACKGROUND', 'citation': 'Becker R, Wegner RD. Detailed screening for fetal anomalies and cardiac defects at the 11-13-week scan. Ultrasound Obstet Gynecol. 2006 Jun;27(6):613-8. doi: 10.1002/uog.2709.'}, {'pmid': '20427794', 'type': 'BACKGROUND', 'citation': 'Abu-Rustum RS, Daou L, Abu-Rustum SE. Role of ultrasonography in early gestation in the diagnosis of congenital heart defects. J Ultrasound Med. 2010 May;29(5):817-21. doi: 10.7863/jum.2010.29.5.817.'}, {'pmid': '17318942', 'type': 'BACKGROUND', 'citation': 'Lombardi CM, Bellotti M, Fesslova V, Cappellini A. Fetal echocardiography at the time of the nuchal translucency scan. Ultrasound Obstet Gynecol. 2007 Mar;29(3):249-57. doi: 10.1002/uog.3948.'}, {'pmid': '8862884', 'type': 'BACKGROUND', 'citation': 'Heifetz SA. The umbilical cord: obstetrically important lesions. Clin Obstet Gynecol. 1996 Sep;39(3):571-87. doi: 10.1097/00003081-199609000-00007. No abstract available.'}, {'pmid': '20859147', 'type': 'BACKGROUND', 'citation': 'Murphy-Kaulbeck L, Dodds L, Joseph KS, Van den Hof M. Single umbilical artery risk factors and pregnancy outcomes. Obstet Gynecol. 2010 Oct;116(4):843-850. doi: 10.1097/AOG.0b013e3181f0bc08.'}, {'pmid': '7898835', 'type': 'BACKGROUND', 'citation': 'Parilla BV, Tamura RK, MacGregor SN, Geibel LJ, Sabbagha RE. The clinical significance of a single umbilical artery as an isolated finding on prenatal ultrasound. Obstet Gynecol. 1995 Apr;85(4):570-2. doi: 10.1016/0029-7844(94)00451-I.'}, {'pmid': '6514541', 'type': 'BACKGROUND', 'citation': 'Heifetz SA. Single umbilical artery. A statistical analysis of 237 autopsy cases and review of the literature. Perspect Pediatr Pathol. 1984 Winter;8(4):345-78.'}, {'pmid': '11704178', 'type': 'BACKGROUND', 'citation': 'Hill LM, Wibner D, Gonzales P, Chenevey P. Validity of transabdominal sonography in the detection of a two-vessel umbilical cord. Obstet Gynecol. 2001 Nov;98(5 Pt 1):837-42. doi: 10.1016/s0029-7844(01)01572-1.'}, {'pmid': '14689527', 'type': 'BACKGROUND', 'citation': "Rembouskos G, Cicero S, Longo D, Sacchini C, Nicolaides KH. Single umbilical artery at 11-14 weeks' gestation: relation to chromosomal defects. Ultrasound Obstet Gynecol. 2003 Dec;22(6):567-70. doi: 10.1002/uog.901."}, {'pmid': '2051544', 'type': 'BACKGROUND', 'citation': 'Nyberg DA, Mahony BS, Luthy D, Kapur R. Single umbilical artery. Prenatal detection of concurrent anomalies. J Ultrasound Med. 1991 May;10(5):247-53. doi: 10.7863/jum.1991.10.5.247.'}, {'pmid': '17410588', 'type': 'BACKGROUND', 'citation': 'Sheiner E, Shoham-Vardi I, Hussey MJ, Pombar X, Strassner HT, Freeman J, Abramowicz JS. First-trimester sonography: is the fetus exposed to high levels of acoustic energy? J Clin Ultrasound. 2007 Jun;35(5):245-9. doi: 10.1002/jcu.20321.'}, {'pmid': '17182711', 'type': 'BACKGROUND', 'citation': 'Sheiner E, Shoham-Vardi I, Pombar X, Hussey MJ, Strassner HT, Abramowicz JS. An increased thermal index can be achieved when performing Doppler studies in obstetric sonography. J Ultrasound Med. 2007 Jan;26(1):71-6. doi: 10.7863/jum.2007.26.1.71.'}, {'pmid': '20040792', 'type': 'BACKGROUND', 'citation': 'American Institute of Ultrasound in Medicine. AIUM practice guideline for the performance of obstetric ultrasound examinations. J Ultrasound Med. 2010 Jan;29(1):157-66. doi: 10.7863/jum.2010.29.1.157. No abstract available.'}, {'pmid': '11392597', 'type': 'BACKGROUND', 'citation': 'Barnett SB, Maulik D; International Perinatal Doppler Society. Guidelines and recommendations for safe use of Doppler ultrasound in perinatal applications. J Matern Fetal Med. 2001 Apr;10(2):75-84. doi: 10.1080/714904312.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the detection rate of two- or three-vessel umbilical cord at the time of nuchal translucency screening between 11 and 13 6/7 weeks gestation.\n\nHypothesis: Detection rate of the number of vessels during first trimester will be as accurate as the detection of vessels during the second trimester.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing nuchal transluscency screening during 11-13+6 weeks gestation, followed by anatomy scan at 18-24 weeks gestation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton or multiple-gestation pregnancies in patients presenting for NT screening between 11 and 13 6/7 weeks gestation and CRL between 45-84mm as determined at the time of the ultrasound\n* Age 18 and older\n\nExclusion Criteria:\n\n* Patients who are incapable of informed consent or minors'}, 'identificationModule': {'nctId': 'NCT01367132', 'briefTitle': 'Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening', 'orgStudyIdInfo': {'id': 'MedStar 2010-450'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Doppler ultrasound', 'type': 'PROCEDURE', 'description': 'Ultrasound using Doppler mode to detect blood flow in umbilical cord vasculature and determine the number of vessels present'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Hospital, MedStar Health', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center, MedStar Health', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Rita W Driggers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington Hospital Center, MedStar Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}