NCT00311064

Brief Summary

Purpose: The purpose of this study is to determine if disturbances in cytokines or factors of the metabolic syndrome, can predict complications in pregnancy, birth, and the perinatal period in pregnant women with type 2 diabetes or who are overweight. At the same time we, the investigators at Rigshospitalet, want to determine if physical activity in the overweight pregnant woman can influence these factors in a favourable way and, with that, improve the progress of pregnancy and birth.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

August 21, 2007

Status Verified

August 1, 2007

First QC Date

April 4, 2006

Last Update Submit

August 20, 2007

Conditions

Inflammation

Outcome Measures

Primary Outcomes (5)

  • perinatal mortality

  • congenital malformations and preeclampsia

  • gestational hypertension and gestational diabetes mellitus (GDM)

  • preterm delivery

  • too large infants (> 2 standard deviation [SD])

Secondary Outcomes (2)

  • delivery by caesarian section

  • induction of labour

Interventions

physical activityBEHAVIORAL

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 30 kg/m2
  • BMI \< 45 kg/m2
  • Healthy
  • Over 18 years of age
  • No earlier preterm delivery (before 37)
  • Singleton pregnancy
  • weeks +/- 1 week of gestation

You may not qualify if:

  • BMI \> 45 kg/m2
  • Earlier preterm delivery (before 37)
  • Not singleton pregnancy
  • Medically treated diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Obstetric Clinic, Juliane Marie Centret

Copenhagen, Østerbro, 2100, Denmark

Location

MeSH Terms

Conditions

Inflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bettina Breitowicz, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 5, 2006

Study Start

March 1, 2006

Study Completion

January 1, 2008

Last Updated

August 21, 2007

Record last verified: 2007-08

Locations

DK(1)