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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Placenta Diseases; Gestational Diabetes

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

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Meryam Sugulle, PhD; Phone Number: +47 22119800; Email: UXSUME@ous-hf.no
• Study Contact Backup: Name: Bendik Fiskå, M.D.; Phone Number: +47 22119800; Email: benfis@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0407
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Women with gestational diabetes; Any treatment. N=200.
Control group; Gestational-age matched, euglycemic, normotensive pregnant women (n=150)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Norwegian SIDS and Stillbirth Society
• Investigators: Principal Investigator: Meryam Sugulle, PhD, Oslo University Hospital, Division of Gynaecology and Obstetrics, Ullevål

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): June 1, 2026
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetes, Gestational; Placenta Diseases
• Other Study ID Numbers: 494097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Depending on when the permission for the dataset usage for the project's outcome measures ends (OUH personal data officer/Regional Ethical Comittee) AND Norwegian legislation regarding personal data protection. It is unlikely that a major part of the data set will be shared openly due to these restrictions on sensitive personal data matters.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No