NCT02564250

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

3 years

First QC Date

September 29, 2015

Last Update Submit

September 29, 2015

Conditions

PregnancyObesity

Outcome Measures

Primary Outcomes (1)

  • Mode of delivery

    3 years

Secondary Outcomes (1)

  • Longitudinal metabolic changes during pregnancy

    1 year

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women with prepregnancy BMI \> 35

You may qualify if:

  • pregnant women with pregestational BMI \> 35

You may not qualify if:

  • diabetes mellitus type 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestre Viken Hospital Trust

Drammen, Buskerud, 3004, Norway

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marie Cecilie P Roland, PhD

    Vestre Viken HF

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bjørn Rishovd Rund, PhD

CONTACT

+4732800000mailto:BjornRishovd.Rund@vestreviken.no

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

September 30, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

September 30, 2015

Record last verified: 2015-09

Locations

NO(1)