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| Name | Class |
|---|---|
| Norwegian SIDS and Stillbirth Society | OTHER |
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The GaP study is designed to close important knowledge gaps by:
The incidence of gestational diabetes mellitus (GDM) is increasing. GDM has potential adverse short and long term health effects for both the women and her offspring, and involves dysfunctional interaction between placenta and the maternal body. The burden for the individual, the health system and society warrants further investigations into the placental-maternal crosstalk in GDM in order to improve personalized pregnancy surveillance and follow-up. In Oslo county, nearly twice as many women who give birth suffer from GDM (5.7%) than from preeclampsia (2.3%). The large obstetric department at Ullevål provides an optimal environment for novel translational studies and clinical practical aspects of GDM. The GaP study is designed to close important knowledge gaps by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with gestational diabetes | Any treatment. N=200. | ||
| Control group | Gestational-age matched, euglycemic, normotensive pregnant women (n=150) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of women with altered levels of circulating senescence markers | Levels of maternal circulating senescence markers, e.g. SAA1, free thiol and related markers, in case group compared to controls | 4 years |
| Number of women with altered levels of tissue-based senescence markers | Expression of markers of senescence in placental tissue, as assesed by immunohistochemistry (e.g. IL-6, p21, p16 and related markers) in case group compared to controls | 4 years |
| Number of women with increased values for postpartum surrogate markers for impaired cardiovascular function | As assessed by circulating maternal levels of cardiovascular biomarkers, e.g. HDL (mmol/l), LDL (mmol/l) and related markers in case group compared to controls | 4 years |
| Number of women with increased values for postpartum surrogate markers for impaired cardiovascular function | As assessed by circulating maternal levels of cardiovascular biomarkers, e.g. GDF-15 (ng/l), NT-pro BNP (ng/l), Troponin (ng/l) and related markers in case group compared to controls | 4 years |
| Number of neonates with adverse neonatal outcome | A composite measure for neonatal outcome will be created using information on fetal acidemia, Apgar-score, asphyxia, intra-/postpartum fetal death, neonatal intubation/mechanical ventilation, meconium aspiration syndrome, netonatal hypoxic-ishcemic encephalopathy, therapeutic hypothermia of the neonate, rate of acute cesarean section (due to suspected fetal distress) and compared in case group and controls | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with operative vaginal delivery due to suspected fetal distress | Rates of operative vaginal deliveries (forceps/vacuum/combined; due to suspected fetal distress) in case and control groups | 4 years |
| Percentage of participants with pathological placenta histology findings in case and control groups |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women with GDM (diagnosed according to guidelines and referred to our outpatient clinic) and healthy, euglycemic pregnant women (Control group: referred for breech evaluation, planning of elective cesarean section, suspected reduced or increased fetal growth with a normal finding at ultrasound). Patients can be recruited from outpatient clinic, prior to induction, at admission for elective cesaerean section or at admission for labor (but not yet in active labor)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meryam Sugulle, PhD | Contact | +47 22119800 | UXSUME@ous-hf.no | |
| Bendik Fiskå, M.D. | Contact | +47 22119800 | benfis@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Meryam Sugulle, PhD | Oslo University Hospital, Division of Gynaecology and Obstetrics, Ullevål | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0407 | Norway |
Depending on when the permission for the dataset usage for the project's outcome measures ends (OUH personal data officer/Regional Ethical Comittee) AND Norwegian legislation regarding personal data protection. It is unlikely that a major part of the data set will be shared openly due to these restrictions on sensitive personal data matters.
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D002318 | Cardiovascular Diseases |
| D010922 | Placenta Diseases |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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Maternal blood (serum, plasma)
As assessed by a senior perinatal pathologist using predefined criteria |
| 4 years |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |