Clinical trial · Interventional
Metformin in Pregnancy in Women With Polycystic Ovary Syndrome
NCT01594697CI-TRIAL-00006890completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study provide a detailed longitudinal evaluation of the gluco-insulinemic assessment of pregnant PCOS women under metformin treatment. 47 non diabetic Polycystic Ovary Syndrome (PCOS) women became pregnant during metformin treatment and continued taking the drug during gestation. An oral glucose tolerance test and euglycaemic hyperinsulinaemic clamp were performed at each trimester of gestation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- metformin
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- incidence of gestational diabetes
Secondary outcomes (5)
- measure
- rate of spontaneous abortion
- measure
- number of hypertensive disorders
- measure
- number of live births
- measure
- number of newborns with macrosomia
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * age 18-40 yr, * metformin treatment for at least 3 months before entering the pregnancy, * gestational age between 5 and 12 wk Exclusion Criteria: * diabetes mellitus * significant liver or renal impairment * neoplasms and other endocrine diseases * the use of drugs other than metformin able to interfere with glucose and insulin metabolism.
References
Publications (1)
- DERIVEDRomualdi D, De Cicco S, Gagliano D, Busacca M, Campagna G, Lanzone A, Guido M. How metformin acts in PCOS pregnant women: insights into insulin secretion and peripheral action at each trimester of gestation. Diabetes Care. 2013 Jun;36(6):1477-82. doi: 10.2337/dc12-2071. Epub 2013 Jan 11. PMID 23315599