Clinical trial NCT05872009: Gestational Diabetes Mellitus: "Placental-maternal Crosstalk and Future Health"
Official title: The GaP Study: Gestational Diabetes Mellitus: "Placental-maternal Crosstalk and Future Health
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gestational Diabetes
Cardiovascular Diseases
Placenta Diseases
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian SIDS and Stillbirth Society
First posted: 2023-05-23
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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

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.

Primary outcomes:
measure: Number of women with altered levels of circulating senescence markers
timeFrame: 4 years
measure: Number of women with altered levels of tissue-based senescence markers
timeFrame: 4 years
measure: Number of women with increased values for postpartum surrogate markers for impaired cardiovascular function
timeFrame: 4 years
measure: Number of women with increased values for postpartum surrogate markers for impaired cardiovascular function
timeFrame: 4 years
measure: Number of neonates with adverse neonatal outcome
timeFrame: 4 years
Secondary outcomes:
measure: Number of participants with operative vaginal delivery due to suspected fetal distress
timeFrame: 4 years
measure: Percentage of participants with pathological placenta histology findings in case and control groups
timeFrame: 4 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital, Division of Gynaecology and Obstetrics, Ullevål
name: Meryam Sugulle, PhD
role: PRINCIPAL_INVESTIGATOR
References: