Oral Antidiabetic Agents in Pregnancy
Primary Purpose
Gestational Diabetes
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Metformin
Glyburide
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes focused on measuring gestational diabetes, metformin, glyburide, fetal growth, capillar glucose
Eligibility Criteria
Inclusion Criteria:
- Eligible women between 18-45 years diagnosed with gestational diabetes, according to the WHO criteria (19), ratified the public network for prenatal care at the Clinic for Diabetes and Pregnancy.
- Women with singleton pregnancy and gestational age not exceeding 30 weeks at the time of enrollment, calculated from ultrasound (U.S.) Obstetric performed before the 20th week of pregnancy will be enrolled.
Exclusion Criteria:
- Women who present enrollment in the diagnosis of chronic hypertension, heart disease or chronic lung disease intrauterine restricted or preterm labor, growth, or even chronic diarrhea will be excluded
Sites / Locations
- Hospital de Clínicas de Porto AlegreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Glyburide
Metformin
Arm Description
Glyburide 2,5 mg
Metformin 500mg bid
Outcomes
Primary Outcome Measures
fetal growth
fetal growth will be assessed every 3 weeks by obstetric ultrasound during pregnancy until delivery
Secondary Outcome Measures
insulin requirements to achieve glucose targets
every week patients will have one whole day in the hospital to monitor capillar glucose levels
Full Information
NCT ID
NCT02091336
First Posted
February 25, 2014
Last Updated
March 18, 2014
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02091336
Brief Title
Oral Antidiabetic Agents in Pregnancy
Official Title
Oral Antidiabetic Agents on Gestational Diabetes: Modulating Effect on Fetal Growth - a Clinical Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 .
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
gestational diabetes, metformin, glyburide, fetal growth, capillar glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glyburide
Arm Type
Active Comparator
Arm Description
Glyburide 2,5 mg
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Metformin 500mg bid
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage, Glifage
Intervention Description
patients treatment
Intervention Type
Drug
Intervention Name(s)
Glyburide
Other Intervention Name(s)
Glibenclamida, Glucovance
Intervention Description
patients treatment
Primary Outcome Measure Information:
Title
fetal growth
Description
fetal growth will be assessed every 3 weeks by obstetric ultrasound during pregnancy until delivery
Time Frame
up to 9 months
Secondary Outcome Measure Information:
Title
insulin requirements to achieve glucose targets
Description
every week patients will have one whole day in the hospital to monitor capillar glucose levels
Time Frame
up to 9 months
Other Pre-specified Outcome Measures:
Title
hypoglycaemia
Description
medications will be suspended if patients present with repeated hypoglycaemia
Time Frame
up to 9 months
Title
maternal weight gain
Time Frame
up to 9 months
Title
neonatal 5th minute apgar
Time Frame
5 minutes after birth
Title
neonatal hypoglycaemia and respiratory distress
Time Frame
48 hours after birth
Title
neonatal need of intensive care
Time Frame
48 hours after birth
Title
need of c section
Time Frame
day of birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible women between 18-45 years diagnosed with gestational diabetes, according to the WHO criteria (19), ratified the public network for prenatal care at the Clinic for Diabetes and Pregnancy.
Women with singleton pregnancy and gestational age not exceeding 30 weeks at the time of enrollment, calculated from ultrasound (U.S.) Obstetric performed before the 20th week of pregnancy will be enrolled.
Exclusion Criteria:
Women who present enrollment in the diagnosis of chronic hypertension, heart disease or chronic lung disease intrauterine restricted or preterm labor, growth, or even chronic diarrhea will be excluded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Lucia R Oppermann, PhD
Phone
55 51 33598117
Email
maluopp@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa K Genro, PhD
Phone
55 51 81313734
Email
vanessagenro@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Lucia R Oppermann, PhD Prf
Organizational Affiliation
HCPA-UFRGS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vanessa K Genro, PhD
Organizational Affiliation
HCPA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Oral Antidiabetic Agents in Pregnancy
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