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

NCT05872009 | Not Yet Recruiting DMC

• 1 other identifier: 494097
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The GaP study is designed to close important knowledge gaps by:

1. 1.exploring placental health and cellular ageing in GDM and the association with neonatal outcome
2. 2.evaluating the effectiveness of current and novel maternal health follow-up strategies after GDM

Conditions

Gestational Diabetes; Cardiovascular Diseases; Placenta Diseases

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Number of participants with operative vaginal delivery due to suspected fetal distress

  4 years

• Percentage of participants with pathological placenta histology findings in case and control groups

  4 years

Study Arms (2)

Women with gestational diabetes

Any treatment. N=200.

Control group

Gestational-age matched, euglycemic, normotensive pregnant women (n=150)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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)

You may qualify if:

• Pregnant women \>18 years with GDM giving birth at Oslo University hospital Ullevål.
• Control group of gestational age matched euglycemic, normotensive pregnancies

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian SIDS and Stillbirth Society: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0407, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal blood (serum, plasma)

MeSH Terms

Conditions

Diabetes, Gestational; Cardiovascular Diseases; Placenta Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Meryam Sugulle, PhD

  Oslo University Hospital, Division of Gynaecology and Obstetrics, Ullevål

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meryam Sugulle, PhD

CONTACT

+47 22119800; UXSUME@ous-hf.no

Bendik Fiskå, M.D.

CONTACT

+47 22119800; benfis@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: May 23, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

NO (1)