NCT01594697

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
Last Updated

May 11, 2012

Status Verified

May 1, 2012

First QC Date

May 7, 2012

Last Update Submit

May 10, 2012

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • incidence of gestational diabetes

Secondary Outcomes (5)

  • rate of spontaneous abortion

  • number of hypertensive disorders

  • number of live births

  • number of newborns with macrosomia

  • incidence of delivery by caesarian section

Study Arms (1)

metformin

EXPERIMENTAL
Drug: Metformin

Interventions

MetforminDRUG
metformin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-40 yr,
  • metformin treatment for at least 3 months before entering the pregnancy,
  • gestational age between 5 and 12 wk

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Sacred Heart

Rome, Rome, 00168, Italy

Location

Related Publications (1)

  • Romualdi 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: 23315599DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2012

First Posted

May 9, 2012

Last Updated

May 11, 2012

Record last verified: 2012-05

Locations

IT(1)