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

NCT ID: NCT05872009

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-06-30

Brief 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

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:

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

Conditions

Gestational Diabetes; Cardiovascular Diseases; Placenta Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women with gestational diabetes

Any treatment. N=200.

No interventions assigned to this group

Control group

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Norwegian SIDS and Stillbirth Society

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Meryam Sugulle

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meryam Sugulle, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, Division of Gynaecology and Obstetrics, Ullevål

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

Central Contacts

Meryam Sugulle, PhD

Role: CONTACT

UXSUME@ous-hf.no

+47 22119800

Bendik Fiskå, M.D.

Role: CONTACT

benfis@ous-hf.no

+47 22119800

Other Identifiers

494097

Identifier Type: -

Identifier Source: org_study_id