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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

Tracking Information
First Submitted Date May 2, 2015
First Posted Date May 14, 2015
Last Update Posted Date January 20, 2016
Study Start Date June 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2015)
Cutoff body mass index for the use of transvaginal ultrasound for aneuploidy risk assessment. [ Time Frame: 30 minutes ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 13, 2015)
  • 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
  • The tolerance of the woman for trans-vaginal ultrasound. [ Time Frame: 30 minutes ]
    preference of the patients towards transabdominal and transvaginal ultrasound
  • The harmful effect to the patient [ Time Frame: 12 hours ]
    Infection, Bleeding, Injury to vagina or cervix and uterine irritability.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Can Increased Body Mass Index Prevent Adequate Ultrasound Examination for Trisomy 21 Risk Assessment?
Official Title Can Increased Body Mass Index Prevent Adequate Ultrasound Examination for Trisomy 21 Risk Assessment?
Brief Summary Determine Cutoff BMI at which transabdominal sonography (TAS) is not satisfactory for aneuploidy risk assessment.
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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Ultrasound Quality
Intervention Other: ultrasound
trans abdominal or trans vaginal ultrasound to detect some of the soft markers of trisomy screening
Study Groups/Cohorts
  • 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.
    Intervention: Other: ultrasound
  • 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.
    Intervention: Other: ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 13, 2015)
200
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number NCT02443597
Other Study ID Numbers AFHSRMREC/2015/OB/GYNAE/053
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ahmed abdulmoneim altraigey, Benha University
Study Sponsor Benha University
Collaborators Armed Forces Hospitals, Southern Region, Saudi Arabia
Investigators
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
PRS Account Benha University
Verification Date January 2016