Clinical trial NCT02487641: Obese Pregnant Women: Optimizing Fetal Ultrasound
Official title: Obese Pregnant Women: Optimizing Mid-trimester Fetal Ultrasound for Risk Estimation During Pregnancy and Childhood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Fetal Malformation
Keywords: Ultrasound
mid-trimester
Obesity
pregnancy
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Technical University of Denmark
First posted: 2015-07-01
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Image quality of ultrasound at 15 compared with 21 weeks of gestation.
timeFrame: 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 outcomes:
measure: Image quality of ultrasound at 13 compared with 15 weeks of gestation.
timeFrame: 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)
measure: Analyses of BMI, visceral to subcutaneous fat ratio, distance from cutis to amnion and hip-waist ratio´s influence on image quality.
timeFrame: 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).
measure: Weight estimate
timeFrame: 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.
measure: Amnion fluid in obese
timeFrame: The participants will be examined for an hour at three different stages of the pregnancy (GA 15, GA 21, GA 36 weeks)
measure: Crown-rump length (CRL) measurement transvaginal and abdominal
timeFrame: The participants will be examined for an hour at GA 13 weeks.
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: Department of Gynaechology and Obstetrics, Holbaek Hospital
Study officials:
affiliation: Department of obstetrics and gynecology, Holbæk Hospital, Denmark
name: Ida Näslund Thagaard, M.D.
role: PRINCIPAL_INVESTIGATOR
References: