Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02564250
• Other study ID #: REK 2015/1017
• 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

• Obesity
• Pregnancy

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