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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05872009
Other study ID # 494097
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date June 2026

Study information

Verified date May 2023
Source Oslo University Hospital
Contact Meryam Sugulle, PhD
Phone +47 22119800
Email UXSUME@ous-hf.no
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 350
Est. completion date June 2026
Est. primary completion date June 2026
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital Norwegian SIDS and Stillbirth Society

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Secondary 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
Secondary Percentage of participants with pathological placenta histology findings in case and control groups As assessed by a senior perinatal pathologist using predefined criteria 4 years
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