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

NCT ID: NCT01367132

Last Updated: 2013-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Umbilical Cord

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Doppler ultrasound

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rita W Driggers, MD

Role: PRINCIPAL_INVESTIGATOR

Washington Hospital Center, MedStar Health

Locations

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Georgetown University Hospital, MedStar Health

Washington D.C., District of Columbia, United States

Site Status

Washington Hospital Center, MedStar Health

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 1827525 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17197615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9476332 (View on PubMed)

Dugoff L. Ultrasound diagnosis of structural abnormalities in the first trimester. Prenat Diagn. 2002 Apr;22(4):316-20. doi: 10.1002/pd.309.

Reference Type BACKGROUND
PMID: 11981912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10492104 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10426606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16570262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20427794 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17318942 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8862884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20859147 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7898835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6514541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11704178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14689527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2051544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17410588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17182711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20040792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11392597 (View on PubMed)

Other Identifiers

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MedStar 2010-450

Identifier Type: -

Identifier Source: org_study_id

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