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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01367132
First received: June 1, 2011
Last updated: February 20, 2013
Last verified: February 2013
  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:
    Procedure: Doppler ultrasound
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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.
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

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 July 28, 2014