Oral Antidiabetic Agents in Pregnancy
Recruitment status was: Recruiting
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 .
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Oral Antidiabetic Agents on Gestational Diabetes: Modulating Effect on Fetal Growth - a Clinical Randomized Trial|
- fetal growth [ Time Frame: up to 9 months ] [ Designated as safety issue: No ]fetal growth will be assessed every 3 weeks by obstetric ultrasound during pregnancy until delivery
- insulin requirements to achieve glucose targets [ Time Frame: up to 9 months ] [ Designated as safety issue: No ]every week patients will have one whole day in the hospital to monitor capillar glucose levels
- hypoglycaemia [ Time Frame: up to 9 months ] [ Designated as safety issue: No ]medications will be suspended if patients present with repeated hypoglycaemia
- maternal weight gain [ Time Frame: up to 9 months ] [ Designated as safety issue: No ]
- neonatal 5th minute apgar [ Time Frame: 5 minutes after birth ] [ Designated as safety issue: No ]
- neonatal hypoglycaemia and respiratory distress [ Time Frame: 48 hours after birth ] [ Designated as safety issue: No ]
- neonatal need of intensive care [ Time Frame: 48 hours after birth ] [ Designated as safety issue: No ]
- need of c section [ Time Frame: day of birth ] [ Designated as safety issue: No ]
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Glyburide
Glyburide 2,5 mg
Other Name: Glibenclamida, Glucovance
Active Comparator: Metformin
Metformin 500mg bid
Other Name: Glucophage, Glifage
The procedures for monitoring metabolic and obstetrical control , assessments of fetal well -being and indications for interruption are usually adopted in the Outpatient Diabetes and Pregnancy of the institution.
- Patients will be followed since their first appointment in our hospital, around the 20th week of pregnancy- until 8 weeks after labor and delivery. That being said, patients will be followed by an average of 28 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02091336
|Hospital de Clínicas de Porto Alegre|
|Porto Alegre, RS, Brazil, 90035-903|
|Study Chair:||Maria Lucia R Oppermann, PhD Prf||HCPA-UFRGS|
|Principal Investigator:||Vanessa K Genro, PhD||HCPA|