Metformin for the Treatment of Diabetes in Pregnancy | NCT00414245

Studies
Metformin for the Treatment of Diabetes in Pregnancy

NCT00414245

Sponsor

Soroka University Medical Center

Status

Unknown status

Last Update Posted

Dec 21, 2006Estimated

Enrollment

200

Phase

Phase 3

Conditions

Gestational Diabetes
Diabetes Mellitus Type 2

Interventions

metformin

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 20, 2006

First Submission Date that Met QC Criteria

Dec 20, 2006

First Posted Date

Dec 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2006

Last Update Posted Date

Dec 21, 2006Estimated

Name	Class
Ben-Gurion University of the Negev	OTHER

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Name	Type	Description	Arm Group Labels	Other Names
metformin	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women
GDM A2
diabetes mellitus type 2
singleton pregnancy

Exclusion Criteria:

diabetic nephropathy or proliferative retinopathy
cannot swallow tablets

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Boaz Sheizaf, MD	Contact	972-54-2401191		bsheizaf@bgu.ac.il

Overall Officials

Name	Affiliation	Role
Boaz Sheizaf, MD	division of obstetrics and gynecology, soroka university medical center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Obstetrics and Gynecology, Soroka University Medical Center		Beersheba			Israel

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
glycemic control
pregnancy complications