Obese Pregnant Women: Optimizing Fetal Ultrasound

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Fetal Malformation

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.

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Ida Näslund Thagaard, M.D.; Phone Number: 004522890524; Email: idanaeslund@gmail.com/ains@regionsjaelland.dk
• Study Contact Backup: Name: Lone Krebs, M.D; DSMc; Email: lkrb@regionsjaelland.dk

Study Locations

• Denmark
  • Holbaek, Denmark, 4300
    • Recruiting
    • Department of Gynaechology and Obstetrics, Holbaek Hospital
    • Contact: Ida Thagaard, M.D.; Phone Number: +45 59481705; Email: ains@regionsjaelland.dk
    • Contact: Lone Krebs, Dr.Med.; Phone Number: +45 59484264; Email: lkrb@regionsjaelland.dk
    • Principal Investigator: Ida Thagaard, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Moderat Obesity; 60 persons with BMI between 30-34.49 kg/m2
Sever Obesity; 60 persons with BMI above 34.49 kg/m2
Normal weighted; 60 persons with BMI between 18.5-24.49 kg/m2

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Holbaek Sygehus
• Collaborators: Odense University Hospital; Technical University of Denmark
• Investigators: Principal Investigator: Ida Näslund Thagaard, M.D., Department of obstetrics and gynecology, Holbæk Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: June 23, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Ultrasound; Obesity; pregnancy; mid-trimester
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 12-000095