Obese Pregnant Women: Optimizing Fetal Ultrasound

Study Overview
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Brief Summary
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This study aim to evaluate the quality of fetal ultrasound in obese pregnant women. The hypotheses is that an early ultrasound will improve the quality of the ultrasound in obese.

Detailed Description
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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.

Official Title
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Obese Pregnant Women: Optimizing Mid-trimester Fetal Ultrasound for Risk Estimation During Pregnancy and Childhood

Conditions
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Obesity, Fetal Malformation

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moderat Obesity<br>60 persons with BMI between 30-34.49 kg/m2 | |
| Sever Obesity<br>60 persons with BMI above 34.49 kg/m2 | |
| Normal weighted<br>60 persons with BMI between 18.5-24.49 kg/m2 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality of ultrasound at 15 compared with 21 weeks of gestation. | 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. | 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. |  | 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 | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, mid-trimester, Obesity, pregnancy