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because of lack of funding and recruitment problems the study has been closed.
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical activity | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| perinatal mortality | ||
| congenital malformations and preeclampsia | ||
| gestational hypertension and gestational diabetes mellitus (GDM) | ||
| preterm delivery | ||
| too large infants (> 2 standard deviation [SD]) |
| Measure | Description | Time Frame |
|---|---|---|
| delivery by caesarian section | ||
| induction of labour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bettina Breitowicz, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, Obstetric Clinic, Juliane Marie Centret | Copenhagen | Østerbro | 2100 | Denmark |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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