se of diabetes medication to prevent diabetes during pregnancy

Not Applicable

Recruiting

• Conditions: Gestational Diabetes Mellitus; C13.703.170

• Registration Number: RBR-27g66s
• Lead Sponsor: niversidade da Região de Joinville - Univille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Pregnant women will be diagnosed with GDM selected according to the criteria of the World Health Organization; aged over 18 years; singleton pregnancy; with screening for gestational diabetes mellitus (GDM) in early positive pregnancy; gestational age between 11 and 33 weeks; no pathology that interferes with glucose metabolism; no hypersensitivity to metformin hydrochloride or important drug allergy; history or presence of liver disease; renal or gastrointestinal or other conditions that interfere with absorption; distribution; excretion or metabolism of the drug.

Exclusion Criteria

They will be excluded from follow-up losses; intolerance to drugs; desire of the mother and presence of risk to the fetus.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of cases of Gestational Diabetes Mellitus in pregnant women who have made the use of metformin hydrochloride, 2 times a day (breakfast and dinner), the realization of the reduction will be performed by biochemical analysis through oral test of glucose tolerance (OGTT) to be held during the gestational trimesters. It expects a 50% effectiveness in reducing cases of Gestational Diabetes Mellitus which will be proven through statistical tests and comparing the concentrations in the OGTT test and control groups.

Secondary Outcome Measures

Name	Time	Method
Decreased neonatal hypoglycemia in infants whose mothers had made the use of metformin hydrochloride during pregnancy. For evaluation of this variable will be held plasma glucose dosage of newborns according to protocol guidelines of the Brazilian Society of Pediatrics. For realization of the expected outcomes will be performed statistical tests and comparing the concentrations of plasma glucose in babies of mothers of test and control groups.