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Metformin in pregnancy - ND

Metformin in pregnancy - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-003055-20-IT
Enrollment
Unknown
Registered
2007-01-30
Start date
2007-01-01
Completion date
Unknown
Last updated
2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus in pregnancy and iperinsulinism MedDRA version: 9.1 Level: LLT Classification code 10018209 Term: Gestational diabetes

Interventions

Trade Name: METFORAL*50CPR RIV 500MG Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Metformin CAS Number: 1115-70-4 Concentration unit: mg milligram(s) Concentration type: equal Concent

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: pregravidic BMI 27 Kg/m2, increase of weight 0.5 Kg/week, previous getstional diabetes, diagnosis of PCOs Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: renal insufficiency, liver and cardiovascolar diseases, high risk pregnancy

Design outcomes

Primary

MeasureTime frame
Main Objective: To estimate if metformin is a treatment of women with gestational diabetes and if it delaies the manifestation;Secondary Objective: To estimate the effect of this therapy on the foetus and on the maternal metabolism;Primary end point(s): the use of metformin in pregnancy—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026