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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02443597
Enrollment
200
Registered
2015-05-14
Start date
2015-06-30
Completion date
2016-01-31
Last updated
2016-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasound Quality

Keywords

ultrasound, trisomy screening, obesity

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.

Interventions

OTHERultrasound

trans abdominal or trans vaginal ultrasound to detect some of the soft markers of trisomy screening

Sponsors

Armed Forces Hospitals, Southern Region, Saudi Arabia
CollaboratorOTHER_GOV
Benha University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Cutoff body mass index for the use of transvaginal ultrasound for aneuploidy risk assessment.30 minutes

Secondary

MeasureTime frameDescription
The harmful effect to the patient12 hoursInfection, Bleeding, Injury to vagina or cervix and uterine irritability.
The time of the study. (time needed for satisfactory ultrasound risk assessment in minutes)30 minutestime needed for satisfactory ultrasound risk assessment in minutes
The tolerance of the woman for trans-vaginal ultrasound.30 minutespreference of the patients towards transabdominal and transvaginal ultrasound

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026