Oral Antidiabetic Agents in Pregnancy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02091336|
Recruitment Status : Unknown
Verified January 2014 by Hospital de Clinicas de Porto Alegre.
Recruitment status was: Recruiting
First Posted : March 19, 2014
Last Update Posted : March 19, 2014
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 .
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes||Drug: Metformin Drug: Glyburide||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Antidiabetic Agents on Gestational Diabetes: Modulating Effect on Fetal Growth - a Clinical Randomized Trial|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2016|
Active Comparator: Glyburide
Glyburide 2,5 mg
Other Name: Glibenclamida, Glucovance
Active Comparator: Metformin
Metformin 500mg bid
Other Name: Glucophage, Glifage
- fetal growth [ Time Frame: up to 9 months ]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 ]every week patients will have one whole day in the hospital to monitor capillar glucose levels
- hypoglycaemia [ Time Frame: up to 9 months ]medications will be suspended if patients present with repeated hypoglycaemia
- maternal weight gain [ Time Frame: up to 9 months ]
- neonatal 5th minute apgar [ Time Frame: 5 minutes after birth ]
- neonatal hypoglycaemia and respiratory distress [ Time Frame: 48 hours after birth ]
- neonatal need of intensive care [ Time Frame: 48 hours after birth ]
- need of c section [ Time Frame: day of birth ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02091336
|Contact: Maria Lucia R Oppermann, PhD||55 51 firstname.lastname@example.org|
|Contact: Vanessa K Genro, PhD||55 51 email@example.com|
|Hospital de Clínicas de Porto Alegre||Recruiting|
|Porto Alegre, RS, Brazil, 90035-903|
|Study Chair:||Maria Lucia R Oppermann, PhD Prf||HCPA-UFRGS|
|Principal Investigator:||Vanessa K Genro, PhD||HCPA|