Obese Pregnant Women: Optimizing Fetal Ultrasound

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02487641
• Other study ID #: 12-000095
• Status: Recruiting
• Phase: N/A
• First received: June 23, 2015
• Last updated: November 9, 2015
• Start date: June 2015
• Est. completion date: March 2017

Study information

• Verified date: November 2015
• Source: Holbaek Sygehus
• Contact: Ida Näslund Thagaard, M.D.
• Phone: 004522890524
• Email: idanaeslund[@]gmail.com/ains[@]regionsjaelland.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Abnormalities
• Fetal Malformation
• Obesity

Locations

Country	Name	City	State
Denmark	Department of Gynaechology and Obstetrics, Holbaek Hospital	Holbaek

Sponsors (3)

Lead Sponsor	Collaborator
Holbaek Sygehus	Odense University Hospital, Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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).	No
Secondary	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.	No
Secondary	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)	No
Secondary	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.	No