NCT02487641

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

1.6 years

First QC Date

June 23, 2015

Last Update Submit

November 9, 2015

Conditions

ObesityFetal Malformation

Keywords

Ultrasoundmid-trimesterObesitypregnancy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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.

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Age ≥ 18
  • BMI ≥ 30 Kg/m2
  • BMI: 18,5-25 Kg/m2
  • Understand and speak Danish and thereby be able to give confirmed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynaechology and Obstetrics, Holbaek Hospital

Holbæk, 4300, Denmark

RECRUITING

MeSH Terms

Conditions

ObesityCongenital Abnormalities

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ida Näslund Thagaard, M.D.

    Department of obstetrics and gynecology, Holbæk Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ida Näslund Thagaard, M.D.

CONTACT

004522890524idanaeslund@gmail.com/ains@regionsjaelland.dk

Lone Krebs, M.D; DSMc

CONTACT

lkrb@regionsjaelland.dk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2015

First Posted

July 1, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

DK(1)