Ultrasound QualityNCT02443597
Can Increased Body Mass Index Prevent Adequate Ultrasound Examination for Trisomy 21 Risk Assessment?
An observational study of Ultrasound Quality, run by Benha University at 1 site in Saudi Arabia.
Trial summary
Determine Cutoff BMI at which transabdominal sonography (TAS) is not satisfactory for aneuploidy risk assessment. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Ultrasound Quality
- What is being tested?
- ultrasound
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jun 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Inclusion criteria will consist of women who have a live, intrauterine, singleton pregnancy between 11- 14 weeks gestation.
Who may be able to join
- women who have a live, intrauterine, singleton pregnancy between 11- 14 weeks gestation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
antenatal clinic of Armed Forces Hospital, Southern Region
Khamis Mushait, 'Asir Region, 101
About this study
Determine Cutoff BMI at which transabdominal sonography (TAS) is not satisfactory for aneuploidy risk assessment.
Read the 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
- Being tested
- ultrasound
- Keywords
- ultrasound, trisomy screening, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundOther
trans abdominal or trans vaginal ultrasound to detect some of the soft markers of trisomy screening
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutoff body mass index for the use of transvaginal ultrasound for aneuploidy risk assessment.
Measured: 30 minutes
Secondary outcomes (3)
The time of the study. (time needed for satisfactory ultrasound risk assessment in minutes)
time needed for satisfactory ultrasound risk assessment in minutes
Measured: 30 minutes
The tolerance of the woman for trans-vaginal ultrasound.
preference of the patients towards transabdominal and transvaginal ultrasound
Measured: 30 minutes
The harmful effect to the patient
Infection, Bleeding, Injury to vagina or cervix and uterine irritability.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound QualityStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Responsible party
- Principal investigator, ahmed abdulmoneim altraigey, Benha University
- Investigators
- ahmed altraigey, Study director, Benha Universityhaytham atia, Principal investigator, Zagazig Universitynuzhat amer, Principal investigator, Armed Forces Hospitals, Southern Region, Saudi ArabiaMohamed Kolkailah, Study chair, Armed Forces Hospitals, Southern Region, Saudi Arabiamohammed ellaithy, Principal investigator, Ain Shams Universitymagdy eldumairy, Principal investigator, Armed Forces Hospitals, Southern Region, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443597
- Sponsor's protocol ID
- AFHSRMREC/2015/OB/GYNAE/053
- Status last verified
- Jan 2016
- First submitted
- 2 May 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Increased Body Mass Index Prevent Adequate Ultrasound Examination for Trisomy 21 Risk Assessment?
- ClinicalTrials.gov ID
- NCT02443597
- Acronym / sponsor ID
- AFHSRMREC/2015/OB/GYNAE/053
- Conditions
- Ultrasound Quality
- Keywords
- ultrasound, trisomy screening, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese pregnant women | – | Other: ultrasoundWith 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. |
| lean pregnant women | – | Other: ultrasoundWith 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Inclusion criteria will consist of women who have a live, intrauterine, singleton pregnancy between 11- 14 weeks gestation.
Key inclusion criteria (1 listed)
- women who have a live, intrauterine, singleton pregnancy between 11- 14 weeks gestation.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundtrans abdominal or trans vaginal ultrasound to detect some of the soft markers of trisomy screening | Other | lean pregnant women, obese pregnant women |
Primary outcome
Cutoff body mass index for the use of transvaginal ultrasound for aneuploidy risk assessment.
Time frame: 30 minutes
3 secondary outcomes
The time of the study. (time needed for satisfactory ultrasound risk assessment in minutes)
Time frame: 30 minutes
The tolerance of the woman for trans-vaginal ultrasound.
Time frame: 30 minutes
The harmful effect to the patient
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed altraigey study director
Benha University
haytham atia principal investigator
Zagazig University
nuzhat amer principal investigator
Armed Forces Hospitals, Southern Region, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Quality, run by Benha University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutoff body mass index for the use of transvaginal ultrasound for aneuploidy risk assessment. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.