BridgeMD
POEM Study
EU CTIS ID: 2024-519386-21-01
What this study is testing
The central aim is to investigate whether metformin from the start of the diagnosis GDM on top of standard of care may improve the treatment of GDM and related outcomes of mother and child. Metformin is used as a tool to reduce insulin resistance, the underlying cause of GDM. In the POEM study, the effects of metformin on top of standard of care versus standard of care alone in GDM are compared during pregnancy until 6 weeks after delivery (Phase A), from 6 weeks until 1 year after delivery (Phase B) and from 1 until 20 years after delivery (Phase C) with specified objectives reflected by well-defined clinically relevant endpoints.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Pregnant women with GDM defined as a FPG ≥ 5,3 mmol/l and/or an OGTT with a PG ≥ 7,8 mmol/l, two hours after the oral intake of 75 gram glucose 2. Written informed consent 3. Age 18-45 years 4. Gestational age at inclusion 16-34 weeks 5. HbA1c at inclusion ≤ 48 mmol/mol (6.5% Hb)
You likely can't join if
- 1. Diabetes mellitus before pregnancy, except previous GDM 2. Proteinuria (UACR > 35 mg/mmol) at screening (UTI excluded) 3. Malignancy during the last 5 years before inclusion, except non-melanoma skin cancer 4. Psychiatric and/or mood disorder potentially affecting compliance of treatment 5. Chronic liver disease and/or ASAT and/or ALAT > 3x ULN 6. Chronic renal failure with a GFR < 45 ml/min/1.73m2 7. Chronic pulmonary failure with hypoxia 8. Significantly uncontrolled hypertension – SBP > 160 mm Hg despite medical treatment 9. Chronic treatment with oral corticosteroids 10. Intolerance for metformin and/or earlier use of metformin in this pregnancy 11. Membership of the POEM study group 12. Severe foetal anomaly at inclusion – like major neural tube and/or cardiac malformation 13. Ruptured membranes 14. Multiple pregnancy 15. Bariatric surgery in medical history 16. Hyperemesis gravidarum
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.