Gestational Diabetes Mellitus: "Placental-maternal Crosstalk and Future Health"

Cardiovascular Diseases Clinical Trial

— GaP  

Official title:

The GaP Study: Gestational Diabetes Mellitus: "Placental-maternal Crosstalk and Future Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05872009
• Other study ID #: 494097
• Status: Not yet recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Placenta Diseases

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