Obese Pregnant Women: Optimizing Fetal Ultrasound

NCT ID: NCT02487641

Last Updated: 2015-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Obesity Fetal Malformation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Moderat Obesity

60 persons with BMI between 30-34.49 kg/m2

No interventions assigned to this group

Sever Obesity

60 persons with BMI above 34.49 kg/m2

No interventions assigned to this group

Normal weighted

60 persons with BMI between 18.5-24.49 kg/m2

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Technical University of Denmark

OTHER

Sponsor Role collaborator

Holbaek Sygehus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ida Näslund Thagaard, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of obstetrics and gynecology, Holbæk Hospital, Denmark

Locations

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Department of Gynaechology and Obstetrics, Holbaek Hospital

Holbæk, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Ida Näslund Thagaard, M.D.

Role: CONTACT

Lone Krebs, M.D; DSMc

Role: CONTACT

Facility Contacts

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Ida Thagaard, M.D.

Role: primary

+45 59481705

Lone Krebs, Dr.Med.

Role: backup

+45 59484264

Other Identifiers

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12-000095

Identifier Type: -

Identifier Source: org_study_id

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