Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening

Umbilical Cord Clinical Trial

Official title:

Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367132
• Other study ID #: MedStar 2010-450
• Status: Completed
• Phase: N/A
• First received: June 1, 2011
• Last updated: February 20, 2013
• Start date: February 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Umbilical Cord

Intervention

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

Locations

Country	Name	City	State
United States	Georgetown University Hospital, MedStar Health	Washington	District of Columbia
United States	Washington Hospital Center, MedStar Health	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (20)

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. — View Citation

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

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

Heifetz SA. The umbilical cord: obstetrically important lesions. Clin Obstet Gynecol. 1996 Sep;39(3):571-87. Review. — View 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. — View 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. — View 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):843-50. doi: 10.1097/AOG.0b013e3181f0bc08. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Souka AP, Nicolaides KH. Diagnosis of fetal abnormalities at the 10-14-week scan. Ultrasound Obstet Gynecol. 1997 Dec;10(6):429-42. Review. — View 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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of the number of vessels in the umbilical cord between 11 and 13 6/7 weeks.		11-13+6 weeks	No
Primary	Detection of the number of vessels in the umbilical cord between 18 and 23 6/7 weeks.		18 - 23 6/7 weeks	No
Secondary	Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord between 11 and 13 6/7 weeks.		11-13+6 weeks gestational age	No
Secondary	Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord during the second trimester.		18-24 weeks gestation	No