Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening - Full Text View

Purpose

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.

Hypothesis: Detection rate of the number of vessels during first trimester will be as accurate as the detection of vessels during the second trimester.

Condition	Intervention
Umbilical Cord	Procedure: Doppler ultrasound

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:

Detection of the number of vessels in the umbilical cord between 11 and 13 6/7 weeks. [ Time Frame: 11-13+6 weeks ] [ Designated as safety issue: No ]
Detection of the number of vessels in the umbilical cord between 18 and 23 6/7 weeks. [ Time Frame: 18 - 23 6/7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord between 11 and 13 6/7 weeks. [ Time Frame: 11-13+6 weeks gestational age ] [ Designated as safety issue: No ]
Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord during the second trimester. [ Time Frame: 18-24 weeks gestation ] [ Designated as safety issue: No ]

Enrollment:	123
Study Start Date:	February 2011
Study Completion Date:	January 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Ultrasound using Doppler mode to detect blood flow in umbilical cord vasculature and determine the number of vessels present

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients undergoing nuchal transluscency screening during 11-13+6 weeks gestation, followed by anatomy scan at 18-24 weeks gestation.

Criteria

Inclusion Criteria:

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
Age 18 and older

Exclusion Criteria:

Patients who are incapable of informed consent or minors

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367132

Locations

United States, District of Columbia
Washington Hospital Center, MedStar Health
Washington, District of Columbia, United States, 20010
Georgetown University Hospital, MedStar Health
Washington, District of Columbia, United States, 20007

Sponsors and Collaborators

Medstar Research Institute

Investigators

Principal Investigator:

Rita W Driggers, MD

Washington Hospital Center, MedStar Health

More Information

Publications:

Cuckle H, Nanchahal K, Wald N. Birth prevalence of Down's syndrome in England and Wales. Prenat Diagn. 1991 Jan;11(1):29-34.

ACOG Committee on Practice Bulletins. ACOG Practice Bulletin No. 77: screening for fetal chromosomal abnormalities. Obstet Gynecol. 2007 Jan;109(1):217-27.

Souka AP, Nicolaides KH. Diagnosis of fetal abnormalities at the 10-14-week scan. Ultrasound Obstet Gynecol. 1997 Dec;10(6):429-42. Review. No abstract available.

Dugoff L. Ultrasound diagnosis of structural abnormalities in the first trimester. Prenat Diagn. 2002 Apr;22(4):316-20. Review.

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.

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. Review. No abstract available.

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.

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.

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.

Heifetz SA. The umbilical cord: obstetrically important lesions. Clin Obstet Gynecol. 1996 Sep;39(3):571-87. Review. No abstract available.

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):843-50

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.

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.

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.

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.

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.

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.

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.

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. No abstract available.

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.

Responsible Party:	Medstar Research Institute
ClinicalTrials.gov Identifier:	NCT01367132 History of Changes
Other Study ID Numbers:	MedStar 2010-450
Study First Received:	June 1, 2011
Last Updated:	February 20, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Medstar Research Institute:

ultrasound
first trimester
umbilical cord

ClinicalTrials.gov processed this record on May 21, 2013