Gestational Diabetes Mellitus: "Placental-maternal Crosstalk and Future Health"
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorOslo University Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women >18 years with GDM giving birth at Oslo University hospital Ullevål.
Control group of gestational age matched euglycemic, normotensive pregnancies
Disqualifiers
reduced fetal movements,
epilepsy
thyroidea dysfunction
hypertensive disorder of pregnancy
Trial population
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)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
350 Participants
are grouped into 2 trial groupsGroup A: Women with gestational diabetes
Group B: Control group
Trial outcomes
Primary outcomes
1
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
Time frame
4 years2
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
Time frame
4 years3
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
Time frame
4 years4
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
Time frame
4 yearsSecondary outcomes
1
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
Time frame
4 years2
Percentage of participants with pathological placenta histology findings in case and control groups
As assessed by a senior perinatal pathologist using predefined criteria
Time frame
4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
Norwegian SIDS and Stillbirth Society
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: