Pregnancy Outcomes: Effects of Metformin Study (POEM Study), a long term randomized controlled study in gestational diabetes mellitus

Phase 3

Recruiting

• Conditions: Gestational Diabetes Mellitus; 10018424; 10010273

• Registration Number: NL-OMON54531
• Lead Sponsor: Bethesda Diabetes Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

- Pregnant women with gestational diabetes mellitus (GDM) defined as a FPG >/=
5,3 mMol and/or an OGTT with a PG >/= 7,8 mMol, two hours after the oral intake
of 75 gram glucose
- Written informed consent
- Age 18-45 years
- Gestational age at inclusion 16-34 weeks
- HbA1c at inclusion <= 48 mmol/mol (6.5% Hb)

Exclusion Criteria

- Diabetes Mellitus before pregnancy, except previous GDM
- Proteïnuria (ACR > 35 mg/mmol) at screening
- Malignancy during the last 5 years before inclusion, except non-melanoma skin
cancer
- Psychiatric and/or mood disorder potentially affecting compliance of treatment
- Chronic liver failure and/or ASAT and/or ALAT > 3x ULN
- Chronic renal failure with a GFR < 45 ml/min/1.73m2
- Chronic pulmonary failure with hypoxia
- Significantly uncontrolled hypertension - SBP > 160 mm Hg despite medical
treatment
- Chronic treatment with oral corticosteroids
- Intolerance for metformin and/or earlier use of metformin in this pregnancy
- Membership of the POEM study group
- Severe fetal anomaly at inclusion - like major neural tube defect or
malformation of heart and/or large vessels
- Ruptured membranes
- Gemelli (twin pregnancy)
- Bariatric surgery in medical history
- Current hyperemesis gravidarum

Study & Design

• Study Type: Interventional
• Study Design: Not specified