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

NCT ID: NCT02443597

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-01-31

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.

Conditions

Ultrasound Quality

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ultrasound

Intervention Type: OTHER

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

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.

ultrasound

Intervention Type: OTHER

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

Interventions

ultrasound

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Armed Forces Hospitals, Southern Region, Saudi Arabia

OTHER_GOV

Sponsor Role: collaborator

Benha University

OTHER

Sponsor Role: lead

Responsible Party

ahmed abdulmoneim altraigey

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ahmed altraigey

Role: STUDY_DIRECTOR

Benha University

haytham atia

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

nuzhat amer

Role: PRINCIPAL_INVESTIGATOR

Armed Forces Hospitals, Southern Region, Saudi Arabia

Mohamed Kolkailah

Role: STUDY_CHAIR

Armed Forces Hospitals, Southern Region, Saudi Arabia

mohammed ellaithy

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

magdy eldumairy

Role: PRINCIPAL_INVESTIGATOR

Armed Forces Hospitals, Southern Region, Saudi Arabia

Locations

antenatal clinic of Armed Forces Hospital, Southern Region

Khamis Mushait, 'Asir Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

AFHSRMREC/2015/OB/GYNAE/053

Identifier Type: -

Identifier Source: org_study_id