Viewing Study NCT02564250


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Study NCT ID: NCT02564250
Status: UNKNOWN
Last Update Posted: 2015-09-30
First Post: 2015-09-29
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
Sponsor: Vestre Viken Hospital Trust
Organization:

Study Overview

Official Title: Healthy Mother - Lifelong Health: A Longitudinal Study on Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
Status: UNKNOWN
Status Verified Date: 2015-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: