Umbilical CordNCT01367132
Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening
An observational study of Umbilical Cord, run by Medstar Health Research Institute at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Umbilical Cord
- What is being tested?
- Doppler ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 123 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing nuchal transluscency screening during 11-13+6 weeks gestation, followed by anatomy scan at 18-24 weeks gestation.
Who may be able to join
- 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
Who cannot join
- Patients who are incapable of informed consent or minors
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Georgetown University Hospital, MedStar Health
Washington D.C., District of Columbia, 20007
Washington Hospital Center, MedStar Health
Washington D.C., District of Columbia, 20010
About this study
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.
- Conditions
- Umbilical Cord
- Being tested
- Doppler ultrasound
- Keywords
- ultrasound, first trimester, umbilical cord
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasoundProcedure or surgery
Ultrasound using Doppler mode to detect blood flow in umbilical cord vasculature and determine the number of vessels present
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of the number of vessels in the umbilical cord between 11 and 13 6/7 weeks.
Measured: 11-13+6 weeks
Detection of the number of vessels in the umbilical cord between 18 and 23 6/7 weeks.
Measured: 18 - 23 6/7 weeks
Secondary outcomes (2)
Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord between 11 and 13 6/7 weeks.
Measured: 11-13+6 weeks gestational age
Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord during the second trimester.
Measured: 18-24 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Umbilical CordStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita W Driggers, MD, Principal investigator, Washington Hospital Center, MedStar Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367132
- Sponsor's protocol ID
- MedStar 2010-450
- Status last verified
- Feb 2013
- First submitted
- 1 Jun 2011
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1002/pd.1970110106.
PubMed 1827525ACOG 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.
PubMed 17197615Souka 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.
PubMed 9476332Dugoff L. Ultrasound diagnosis of structural abnormalities in the first trimester. Prenat Diagn. 2002 Apr;22(4):316-20. doi: 10.1002/pd.309.
PubMed 11981912Whitlow 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.
PubMed 10492104Economides 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.
PubMed 10426606Becker 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.
PubMed 16570262Abu-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.
PubMed 20427794Lombardi 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.
PubMed 17318942Heifetz 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.
PubMed 8862884Murphy-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.
PubMed 20859147Parilla 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.
PubMed 7898835Heifetz 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.
PubMed 6514541Hill 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.
PubMed 11704178Rembouskos 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.
PubMed 14689527
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening
- ClinicalTrials.gov ID
- NCT01367132
- Acronym / sponsor ID
- MedStar 2010-450
- Conditions
- Umbilical Cord
- Keywords
- ultrasound, first trimester, umbilical cord
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing nuchal transluscency screening during 11-13+6 weeks gestation, followed by anatomy scan at 18-24 weeks gestation.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who are incapable of informed consent or minors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler ultrasoundUltrasound using Doppler mode to detect blood flow in umbilical cord vasculature and determine the number of vessels present | Procedure or surgery | – |
Primary outcome
Detection of the number of vessels in the umbilical cord between 11 and 13 6/7 weeks.
Time frame: 11-13+6 weeks
Detection of the number of vessels in the umbilical cord between 18 and 23 6/7 weeks.
Time frame: 18 - 23 6/7 weeks
2 secondary outcomes
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
Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord during the second trimester.
Time frame: 18-24 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
- Background: PubMed 1827525Cuckle 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.
- Background: PubMed 17197615ACOG 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.
- Background: PubMed 9476332Souka 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.
- Background: PubMed 11981912Dugoff L. Ultrasound diagnosis of structural abnormalities in the first trimester. Prenat Diagn. 2002 Apr;22(4):316-20. doi: 10.1002/pd.309.
- Background: PubMed 10492104Whitlow 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.
- Background: PubMed 10426606Economides 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.
- Background: PubMed 16570262Becker 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.
- Background: PubMed 20427794Abu-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.
- Background: PubMed 17318942Lombardi 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.
- Background: PubMed 8862884Heifetz 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.
- Background: PubMed 20859147Murphy-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.
- Background: PubMed 7898835Parilla 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita W Driggers, MD principal investigator
Washington Hospital Center, MedStar Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Umbilical Cord, run by Medstar Health Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of the number of vessels in the umbilical cord between 11 and 13 6/7 weeks. (time frame: 11-13+6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01367132, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2013.