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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02564250
Other study ID # REK 2015/1017
Secondary ID
Status Recruiting
Phase N/A
First received September 29, 2015
Last updated September 29, 2015
Start date September 2015
Est. completion date December 2018

Study information

Verified date September 2015
Source Vestre Viken Hospital Trust
Contact Bjørn Rishovd Rund, PhD
Phone +4732800000
Email mailto:BjornRishovd.Rund@vestreviken.no
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial Summary

The purpose of this study is to study longitudinal changes in maternal metabolism and pregnancy outcomes in obese pregnant women.


Description:

We will study how normal metabolic changes of pregnancy are modified in obesity and investigate the consequences of altered fat and carbohydrate metabolism for pregnancy outcome. The results will aid our understanding of why pregnant obese women and their babies are at higher risk of complications and may highlight potential therapies to reduce these risks.

Overall aim and hypothesis:

The overall aim is to increase knowledge about the relation between obesity, metabolic profile/risk factors and pregnancy outcome in order to improve antenatal care and the health of the next generation.

We hypothesize that obese pregnant women can be differentiated into subgroups according to their metabolic risk profile and their risk of adverse pregnancy outcomes.

Specific aims:

Establish an outpatient clinic for obese pregnant women at Department of Obstetrics, Drammen, Vestre Viken HF in order to:

- Provide improved antenatal care for obese pregnant women who have increased risk of pregnancy complications by offering:

- antenatal care according to national guidelines (Veileder i fødselshjelp 2014)

- fetal surveillance (ultrasound)

- planned delivery according to national and local guidelines

- Conduct an observational study in which clinical and biochemical data will be collected in order to increase knowledge on longitudinal metabolic changes in pregnancies complicated by obesity and how these relate to pregnancy outcomes


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- pregnant women with pregestational BMI > 35

Exclusion Criteria:

- diabetes mellitus type 1

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Norway Vestre Viken Hospital Trust Drammen Buskerud

Sponsors (1)

Lead Sponsor Collaborator
Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mode of delivery 3 years No
Secondary Longitudinal metabolic changes during pregnancy 1 year No
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