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

NCT02443597 | Completed

• 1 other identifier: AFHSRMREC/2015/OB/GYNAE/053
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ultrasound Quality

Keywords

ultrasound; trisomy screening; obesity

Outcome Measures

Primary Outcomes (1)

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

  30 minutes

Secondary Outcomes (3)

• The time of the study. (time needed for satisfactory ultrasound risk assessment in minutes)

  30 minutes

• The tolerance of the woman for trans-vaginal ultrasound.

  30 minutes

• The harmful effect to the patient

  12 hours

Study Arms (2)

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.

Other: ultrasound

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.

Other: ultrasound

Interventions

ultrasound OTHER

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

lean pregnant women; obese pregnant women

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria will consist of women who have a live, intrauterine, singleton pregnancy between 11- 14 weeks gestation.

You may qualify if:

• women who have a live, intrauterine, singleton pregnancy between 11- 14 weeks gestation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead
• Armed Forces Hospitals, Southern Region, Saudi Arabia: collaborator

Study Sites (1)

antenatal clinic of Armed Forces Hospital, Southern Region

Khamis Mushait, 'Asir Region, 101, Saudi Arabia

Location

MeSH Terms

Conditions

Obesity

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• ahmed altraigey

  Benha University

  STUDY DIRECTOR

• haytham atia

  Zagazig University

  PRINCIPAL INVESTIGATOR

• nuzhat amer

  Armed Forces Hospitals, Southern Region, Saudi Arabia

  PRINCIPAL INVESTIGATOR

• Mohamed Kolkailah

  Armed Forces Hospitals, Southern Region, Saudi Arabia

  STUDY CHAIR

• mohammed ellaithy

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• magdy eldumairy

  Armed Forces Hospitals, Southern Region, Saudi Arabia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: May 2, 2015
• First Posted: May 14, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

SA (1)