Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women

• Conditions: Pregnancy; Obesity

• Registration Number: NCT02564250
• Lead Sponsor: Vestre Viken Hospital Trust

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

Study Timeline

• Status Verified: 2015-09
• Study Start: 2015-09
• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-09-29
• Last Update Submitted: 2015-09-29
• Study First Posted: 2015-09-30
• Last Update Posted: 2015-09-30
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• pregnant women with pregestational BMI > 35

Exclusion Criteria

• diabetes mellitus type 1

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mode of delivery	3 years

Secondary Outcome Measures

Name	Time	Method
Longitudinal metabolic changes during pregnancy	1 year

Trial Locations

Locations (1)

Vestre Viken Hospital Trust; 🇳🇴 Drammen, Buskerud, Norway