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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 Summary:

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
Sponsor: Benha University

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Benha University

Dates:
Date Received: May 2, 2015
Date Started: June 2015
Date Completion:
Last Updated: January 16, 2016
Last Verified: January 2016