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Can Increased Body Mass Index Prevent Adequate Ultrasound Examination for Trisomy 21 Risk Assessment?

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ClinicalTrials.gov Identifier: NCT02443597
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : January 20, 2016
Sponsor:
Collaborator:
Armed Forces Hospitals, Southern Region, Saudi Arabia
Information provided by (Responsible Party):
ahmed abdulmoneim altraigey, Benha University

Brief Summary:
Determine Cutoff BMI at which transabdominal sonography (TAS) is not satisfactory for aneuploidy risk assessment.

Condition or disease Intervention/treatment
Ultrasound Quality Other: ultrasound

Detailed Description:

Obesity is a common public health problem which is increasing worldwide at an alarming rate. According to National nutrition survey statistics of 2007, the prevalence of obesity in the kingdom of Saudi Arabia was 23.6% in women and 14% in men. Also the prevalence of overweight in the Saudi community was determined to be 30.7% for men as compared to 28.4% for the women.

First trimester screening between 11-14 weeks gestation is known to be an effective and reliable screening test for Down syndrome and trisomy 18.First trimester screening allows earlier identification of the pregnancy at risk for fetal aneuploidy and anatomic defects, particularly, cardiac anomalies, therefore, providing an option of earlier diagnosis by chorionic villus sampling and analysis of amniocytes.

The well-known association of obesity during pregnancy with a variety of maternal and fetal complications increases the importance of early aneuploidy screening.

Fetal aneuploidy risk assessment is based on a combination of maternal age, prior affected pregnancy or family history, maternal serum biochemical tests and fetal ultrasound markers.

The impact of obesity on the quality of prenatal ultrasound examination is well established with a greater risk for suboptimal visualization, in particular, the fetal cardiac structures and the craniospinal structures only when body mass index above the 90th percentile.

The quality of prenatal screening for aneuploidy via nuchal translucency thickness measurement is significantly limited among obese pregnant women, thus, increased risk of fetal anomalies.

Gandhiet al, have noted that increased BMI is not associated with suboptimal visualization of nuchal translucency, but it is associated with a longer time to perform the first-trimester ultrasound examination for aneuploidy risk assessment, increased need for transvaginal ultrasound examination for optimum nuchal translucency visualization.

There is evidence suggesting that fetal anatomic evaluation in the low-risk gravida can be better accomplished in the first trimester using the transvaginal route, providing a valuable option for obese patients.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Can Increased Body Mass Index Prevent Adequate Ultrasound Examination for Trisomy 21 Risk Assessment?
Study Start Date : June 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016


Group/Cohort Intervention/treatment
obese pregnant women

With the use of trans-abdominal ultrasound, the following measurements will be recorded:

  • Fetal nuchal translucency thickness.
  • Nasal bone.
  • Fetal facio-maxillary angle.
  • The flow across the tricuspid valve as normal or regurgitated.
  • A-wave in the ductus venosus as normal or reversed.
Other: ultrasound
trans abdominal or trans vaginal ultrasound to detect some of the soft markers of trisomy screening

lean pregnant women

With the use of trans-abdominal ultrasound, the following measurements will be recorded:

  • Fetal nuchal translucency thickness.
  • Nasal bone.
  • Fetal facio-maxillary angle.
  • The flow across the tricuspid valve as normal or regurgitated.
  • A-wave in the ductus venosus as normal or reversed.
Other: ultrasound
trans abdominal or trans vaginal ultrasound to detect some of the soft markers of trisomy screening




Primary Outcome Measures :
  1. Cutoff body mass index for the use of transvaginal ultrasound for aneuploidy risk assessment. [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. The time of the study. (time needed for satisfactory ultrasound risk assessment in minutes) [ Time Frame: 30 minutes ]
    time needed for satisfactory ultrasound risk assessment in minutes

  2. The tolerance of the woman for trans-vaginal ultrasound. [ Time Frame: 30 minutes ]
    preference of the patients towards transabdominal and transvaginal ultrasound

  3. The harmful effect to the patient [ Time Frame: 12 hours ]
    Infection, Bleeding, Injury to vagina or cervix and uterine irritability.



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inclusion criteria will consist of women who have a live, intrauterine, singleton pregnancy between 11- 14 weeks gestation.
Criteria

Inclusion Criteria:

  • women who have a live, intrauterine, singleton pregnancy between 11- 14 weeks gestation.

Exclusion Criteria:

  • multiple gestation.
  • fetal size outside of nuchal translucency screening age (crown-rump length (CRL) outside of 46-71 mm).
  • presence of a cystic hygroma.
  • fetal demise.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443597


Locations
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Saudi Arabia
antenatal clinic of Armed Forces Hospital, Southern Region
Khamis Mushait,, Asir,, Saudi Arabia, 101
Sponsors and Collaborators
Benha University
Armed Forces Hospitals, Southern Region, Saudi Arabia
Investigators
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Study Director: ahmed altraigey Benha University
Principal Investigator: haytham atia Zagazig University
Principal Investigator: nuzhat amer Armed Forces Hospitals, Southern Region, Saudi Arabia
Study Chair: Mohamed Kolkailah Armed Forces Hospitals, Southern Region, Saudi Arabia
Principal Investigator: mohammed ellaithy Ain Shams University
Principal Investigator: magdy eldumairy Armed Forces Hospitals, Southern Region, Saudi Arabia

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Responsible Party: ahmed abdulmoneim altraigey, lecturer, Benha University
ClinicalTrials.gov Identifier: NCT02443597    
Other Study ID Numbers: AFHSRMREC/2015/OB/GYNAE/053
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by ahmed abdulmoneim altraigey, Benha University:
ultrasound
trisomy screening
obesity
Additional relevant MeSH terms:
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Down Syndrome
Trisomy
Aneuploidy
Chromosome Aberrations
Pathologic Processes
Chromosome Duplication
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn