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Obese Pregnant Women: Optimizing Fetal Ultrasound

H

Holbaek Sygehus

Status

Unknown

Conditions

Fetal Malformation
Obesity

Study type

Observational

Funder types

Other

Identifiers

NCT02487641
12-000095

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

180 participants in 3 patient groups

Moderat Obesity
Description:
60 persons with BMI between 30-34.49 kg/m2
Sever Obesity
Description:
60 persons with BMI above 34.49 kg/m2
Normal weighted
Description:
60 persons with BMI between 18.5-24.49 kg/m2

Trial contacts and locations

1

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Central trial contact

Ida Näslund Thagaard, M.D.; Lone Krebs, M.D; DSMc

Data sourced from clinicaltrials.gov

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