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

Ultrasound Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443597
• Other study ID #: AFHSRMREC/2015/OB/GYNAE/053
• Status: Completed
• Phase: N/A
• First received: May 2, 2015
• Last updated: January 16, 2016
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ultrasound Quality

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	antenatal clinic of Armed Forces Hospital, Southern Region	Khamis Mushait,	Asir,

Sponsors (2)

Lead Sponsor	Collaborator
Benha University	Armed Forces Hospital, Southern Region, Khamis Mushayt, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cutoff body mass index for the use of transvaginal ultrasound for aneuploidy risk assessment.		30 minutes	No
Secondary	The time of the study. (time needed for satisfactory ultrasound risk assessment in minutes)	time needed for satisfactory ultrasound risk assessment in minutes	30 minutes	No
Secondary	The tolerance of the woman for trans-vaginal ultrasound.	preference of the patients towards transabdominal and transvaginal ultrasound	30 minutes	No
Secondary	The harmful effect to the patient	Infection, Bleeding, Injury to vagina or cervix and uterine irritability.	12 hours	Yes