Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women

NCT ID: NCT02564250

Last Updated: 2015-09-30

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

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Pregnancy Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* pregnant women with pregestational BMI \> 35

Exclusion Criteria

* diabetes mellitus type 1
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vestre Viken Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Cecilie P Roland, PhD

Role: PRINCIPAL_INVESTIGATOR

Vestre Viken HF

Locations

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Vestre Viken Hospital Trust

Drammen, Buskerud, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Bjørn Rishovd Rund, PhD

Role: CONTACT

Phone: +4732800000

Email: mailto:[email protected]

Facility Contacts

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Jeanette Koht, Phd

Role: primary

Other Identifiers

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REK 2015/1017

Identifier Type: -

Identifier Source: org_study_id