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Clinical Trials/NCT02564250
NCT02564250
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Healthy Mother - Lifelong Health: A Longitudinal Study on Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women

Vestre Viken Hospital Trust1 site in 1 country150 target enrollmentSeptember 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Vestre Viken Hospital Trust
Enrollment
150
Locations
1
Primary Endpoint
Mode of delivery
Last Updated
10 years ago

Overview

Brief Summary

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

Detailed 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

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
December 2018
Last Updated
10 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • pregnant women with pregestational BMI \> 35

Exclusion Criteria

  • diabetes mellitus type 1

Outcomes

Primary Outcomes

Mode of delivery

Time Frame: 3 years

Secondary Outcomes

  • Longitudinal metabolic changes during pregnancy(1 year)

Study Sites (1)

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