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Completed

NCT Number: NCT02443597

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

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

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

antenatal clinic of Armed Forces Hospital, Southern Region

Khamis Mushait, 'Asir Region, 101, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ultrasound

Other

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

Primary outcomes

  1. Cutoff body mass index for the use of transvaginal ultrasound for aneuploidy risk assessment.

    Time frame: 30 minutes

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Collaborators

  • Armed Forces Hospitals, Southern Region, Saudi Arabia

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 14, 2015
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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