The GaP Study: Gestational Diabetes Mellitus: "Placental-maternal Crosstalk and Future Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Number of women with altered levels of circulating senescence markers
Study Overview
Brief Summary
The GaP study is designed to close important knowledge gaps by:
- exploring placental health and cellular ageing in GDM and the association with neonatal outcome
- 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:
- exploring placental health and cellular ageing in GDM and the association with neonatal outcome
- evaluating the effectiveness of current and novel maternal health follow-up strategies after GDM
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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,
- •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.
Outcomes
Primary Outcomes
Number of women with altered levels of circulating senescence markers
Time Frame: 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 increased values for postpartum surrogate markers for impaired cardiovascular function
Time Frame: 4 years
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
Number of women with altered levels of tissue-based senescence markers
Time Frame: 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 neonates with adverse neonatal outcome
Time Frame: 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 Outcomes
- Percentage of participants with pathological placenta histology findings in case and control groups(4 years)
- Number of participants with operative vaginal delivery due to suspected fetal distress(4 years)
Investigators
Meryam Sugulle
Principal Investigator
Oslo University Hospital