Obese Pregnant Women: Optimizing Mid-trimester Fetal Ultrasound for Risk Estimation During Pregnancy and Childhood
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Image quality of ultrasound at 15 compared with 21 weeks of gestation.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 30 Kg/m2
- •BMI: 18,5-25 Kg/m2
- •Understand and speak Danish and thereby be able to give confirmed consent.
排除标准
- •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
结局指标
主要结局
Image quality of ultrasound at 15 compared with 21 weeks of gestation.
时间窗: 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.
次要结局
- Image quality of ultrasound at 13 compared with 15 weeks of gestation.(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 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(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(The participants will be examined for an hour at GA 13 weeks.)