Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Overweight

This study has been withdrawn prior to enrollment.
(because of lack of funding and recruitment problems the study has been closed.)
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00311064
First received: April 4, 2006
Last updated: August 20, 2007
Last verified: August 2007

April 4, 2006
August 20, 2007
March 2006
Not Provided
  • perinatal mortality
  • congenital malformations and preeclampsia
  • gestational hypertension and gestational diabetes mellitus (GDM)
  • preterm delivery
  • too large infants (> 2 standard deviation [SD])
Same as current
Complete list of historical versions of study NCT00311064 on ClinicalTrials.gov Archive Site
  • delivery by caesarian section
  • induction of labour
Same as current
Not Provided
Not Provided
 
Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Overweight
Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Only Overweight. The Influence of Physical Activity

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.

Material and Method:

This study falls in two fields:

First 80 pregnant women with type 2 diabetes are followed with determination of cytokines and factors of the metabolic syndrome throughout the pregnancy. The correlation between these variables and the pregnancy and delivery progress is evaluated.

280 overweight (body mass index [BMI] > 30 kg/m2) pregnant women with no medical conditions are examined in the same way. The women are randomized in week 14 to either continue their habitual physical activity or to elevate it by participating in a training program with other pregnant women 3 times weekly.

Both groups will get blood samples taken during fasting approximately 50 ml 3-4 times during the pregnancy.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Inflammation
Behavioral: physical activity
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
280
January 2008
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI > 45 kg/m2
  • Earlier preterm delivery (before 37)
  • Not singleton pregnancy
  • Medically treated diseases
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00311064
01 285157
Not Provided
Not Provided
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Bettina Breitowicz, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP