- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02487641
Obese Pregnant Women: Optimizing Fetal Ultrasound
Obese Pregnant Women: Optimizing Mid-trimester Fetal Ultrasound for Risk Estimation During Pregnancy and Childhood
Study Overview
Status
Conditions
Detailed Description
Ultrasound examination for fetal anomaly is especially challenging in obese gravida. The foetus is more likely to have congenital anomalies and imaging in these patients is technically more difficult.
The investigators hypotheses that an earlier ultrasound with alternative technics will improve the quality and thereby improve the identification of anomalies. By using transvaginal ultrasound and abdominal ultrasound at the window just above the symphysis, were the subcutaneous fat is known to be thinner, the investigators hope to achieve a better overview. This will be done by evaluating fetal ultrasound at three different gestational ages (GA); GA 13, 15 and 21 weeks.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ida Näslund Thagaard, M.D.
- Phone Number: 004522890524
- Email: idanaeslund@gmail.com/ains@regionsjaelland.dk
Study Contact Backup
- Name: Lone Krebs, M.D; DSMc
- Email: lkrb@regionsjaelland.dk
Study Locations
-
-
-
Holbaek, Denmark, 4300
- Recruiting
- Department of Gynaechology and Obstetrics, Holbaek Hospital
-
Contact:
- Ida Thagaard, M.D.
- Phone Number: +45 59481705
- Email: ains@regionsjaelland.dk
-
Contact:
- Lone Krebs, Dr.Med.
- Phone Number: +45 59484264
- Email: lkrb@regionsjaelland.dk
-
Principal Investigator:
- Ida Thagaard, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Sixty pregnant women with BMI ≥ 30 Kg/m2, 60 pregnant women with BMI ≥ 35 Kg/m2 and 60 Kg/m2 pregnant women normal weighted (BMI: 18,5-24,9 Kg/m2) will be included.
Women will be classified by their pre-pregnancy BMI and all pregnant women with an age ≥ 18 will be offered to attend the project and those who accept will be admitted. The recruitment will be performed at Holbæk Hospital and Odense University Hospital.
Description
Inclusion Criteria:
- Age ≥ 18
- BMI ≥ 30 Kg/m2
- BMI: 18,5-25 Kg/m2
- Understand and speak Danish and thereby be able to give confirmed consent.
Exclusion Criteria:
- Multiple gestations
- Overweight (BMI: 25-29,9 Kg/m2)
- Alcohol or drug abuse
- Chronically diseases before pregnancy as diabetes, hypertension, or thyroid diseases
- Gastric bypass or other obesity related surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Moderat Obesity
60 persons with BMI between 30-34.49
kg/m2
|
Sever Obesity
60 persons with BMI above 34.49
kg/m2
|
Normal weighted
60 persons with BMI between 18.5-24.49
kg/m2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Image quality of ultrasound at 15 compared with 21 weeks of gestation.
Time Frame: The participants will be examined for an hour at to different stages of the pregnancy (GA 14+0-15+0, GA 20+0-21+0)
|
Image quality evaluated by experts on a visual analog scale from +50 - -50, parried with standardized ultrasound pictures at the above mentioned GA.
|
The participants will be examined for an hour at to different stages of the pregnancy (GA 14+0-15+0, GA 20+0-21+0)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Image quality of ultrasound at 13 compared with 15 weeks of gestation.
Time Frame: The participants will be examined for an hour at to different stages of the pregnancy (GA 11+3 - 13+0, GA 14+0-15+0)
|
Image quality evaluated by experts on a visual analog scale from +50 - -50, parried with standardized ultrasound pictures at the above mentioned GA.
|
The participants will be examined for an hour at to different stages of the pregnancy (GA 11+3 - 13+0, GA 14+0-15+0)
|
Analyses of BMI, visceral to subcutaneous fat ratio, distance from cutis to amnion and hip-waist ratio´s influence on image quality.
Time Frame: The participants will be examined for an hour at three different stages of the pregnancy (GA 13, GA 15, GA 21 and GA 36 weeks).
|
The participants will be examined for an hour at three different stages of the pregnancy (GA 13, GA 15, GA 21 and GA 36 weeks).
|
|
Weight estimate
Time Frame: The participants will be examined for an hour at GA 36 weeks. The participants will in all be followed until 6 months after birth, which is one year in all.
|
The use of weight estimate in obese pregnant women at GA 36 compared to birthweight.
|
The participants will be examined for an hour at GA 36 weeks. The participants will in all be followed until 6 months after birth, which is one year in all.
|
Amnion fluid in obese
Time Frame: The participants will be examined for an hour at three different stages of the pregnancy (GA 15, GA 21, GA 36 weeks)
|
Measurement of amnion fluid by deepest vertical pocket and amnion fluid index.
|
The participants will be examined for an hour at three different stages of the pregnancy (GA 15, GA 21, GA 36 weeks)
|
Crown-rump length (CRL) measurement transvaginal and abdominal
Time Frame: The participants will be examined for an hour at GA 13 weeks.
|
Measurement of CRL in mm, by using two different probes, transvaginal and abdominal.
|
The participants will be examined for an hour at GA 13 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ida Näslund Thagaard, M.D., Department of obstetrics and gynecology, Holbæk Hospital, Denmark
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-000095
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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