NCT00414245

Brief Summary

The purpose of this study is to determine whether metformin is effective and safe in the treatment of diabetes in pregnancy.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
Last Updated

December 21, 2006

Status Verified

December 1, 2006

First QC Date

December 20, 2006

Last Update Submit

December 20, 2006

Conditions

Outcome Measures

Primary Outcomes (2)

  • glycemic control

  • pregnancy complications

Interventions

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women
  • GDM A2
  • diabetes mellitus type 2
  • singleton pregnancy

You may not qualify if:

  • diabetic nephropathy or proliferative retinopathy
  • cannot swallow tablets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Obstetrics and Gynecology, Soroka University Medical Center

Beersheba, Israel

Location

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Boaz Sheizaf, MD

    division of obstetrics and gynecology, soroka university medical center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Boaz Sheizaf, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 21, 2006

Study Start

January 1, 2007

Last Updated

December 21, 2006

Record last verified: 2006-12

Locations