drugset / Trial / NCT02091336

Oral Antidiabetic Agents in Pregnancy

NCT02091336

Phase 4 Unknown 80 enrolled Hospital de Clinicas de Porto Alegre
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this study is to determine the efficacy of oral treatment with glyburide and metformin controlling excessive fetal growth in women with gestational diabetes, using insulin as a ransom on no response to oral treatment . It is randomized with women who seek care at the Outpatient Diabetes in Pregnancy in our hospital trial Eligible women between 18 - 45anos diagnosed with gestational diabetes , according to the WHO criteria , ratified the public network for prenatal care at the Clinic for Diabetes and Pregnancy HCPA . Women with singleton pregnancy and gestational age not exceeding 30 weeks at the time of enrollment. Pregnant women with indication for pharmacological treatment will be invited to randomization to use of oral , glyburide or metformin antidiabetic . At regular intervals of 2 - 3 weeks fetal growth will be measured with obstetric ultrasonography , until birth. The primary outcomes will be : ( 1 ) weight and gestational age at birth and the index of large for gestational age fetuses ( ≥ 90th percentile for gestational age ) ( 2 ) the use of insulin to achieve glycemic targets according to fetal growth , as an indirect measure of the inefficiency of oral medications .

Timeline

Start
2014-01
Primary completion
2014-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glyburide Small molecule 2.5 mg Oral
Comparator Metformin Small molecule 500 mg Oral

Indications