Cardiovascular Diseases, Gestational Diabetes, Placenta Diseases
Conditions
Brief summary
The GaP study is designed to close important knowledge gaps by: 1. exploring placental health and cellular ageing in GDM and the association with neonatal outcome 2. evaluating the effectiveness of current and novel maternal health follow-up strategies after GDM
Detailed description
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: 1. exploring placental health and cellular ageing in GDM and the association with neonatal outcome 2. evaluating the effectiveness of current and novel maternal health follow-up strategies after GDM
Interventions
None listed
Sponsors
Norwegian SIDS and Stillbirth Society
Oslo University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
* Pregnant women \>18 years with GDM giving birth at Oslo University hospital Ullevål. * Control group of gestational age matched euglycemic, normotensive pregnancies
Exclusion criteria
* reduced fetal movements, * epilepsy * thyroidea dysfunction * hypertensive disorder of pregnancy * non-communicable disease * Communicable disease (such as HIV) * type 1 or type 2 diabetes. * not able to understand Norwegian or English. * under legal guardianship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of women with altered levels of circulating senescence markers | 4 years | Levels of maternal circulating senescence markers, e.g. SAA1, free thiol and related markers, in case group compared to controls |
| Number of women with altered levels of tissue-based senescence markers | 4 years | 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 |
| Number of women with increased values for postpartum surrogate markers for impaired cardiovascular function | 4 years | 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 |
| Number of neonates with adverse neonatal outcome | 4 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with operative vaginal delivery due to suspected fetal distress | 4 years | Rates of operative vaginal deliveries (forceps/vacuum/combined; due to suspected fetal distress) in case and control groups |
| Percentage of participants with pathological placenta histology findings in case and control groups | 4 years | As assessed by a senior perinatal pathologist using predefined criteria |
Countries
Norway
Contacts
Primary ContactMeryam Sugulle, PhD
Backup ContactBendik Fiskå, M.D.
Outcome results
None listed