Oral Antidiabetic Agents in Pregnancy

Oral Antidiabetic Agents on Gestational Diabetes: Modulating Effect on Fetal Growth - a Clinical Randomized Trial

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 Overview

• Status: Unknown
• Conditions: Gestational Diabetes
• Intervention / Treatment: Drug: Glyburide; Drug: Metformin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Recruiting
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Glyburide; Glyburide 2,5 mg	Drug: Glyburide; patients treatment; Other Names: Glibenclamida, Glucovance
ACTIVE_COMPARATOR: Metformin; Metformin 500mg bid	Drug: Metformin; patients treatment; Other Names: Glucophage, Glifage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fetal growth	fetal growth will be assessed every 3 weeks by obstetric ultrasound during pregnancy until delivery	up to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insulin requirements to achieve glucose targets	every week patients will have one whole day in the hospital to monitor capillar glucose levels	up to 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypoglycaemia	medications will be suspended if patients present with repeated hypoglycaemia	up to 9 months
maternal weight gain		up to 9 months
neonatal 5th minute apgar		5 minutes after birth
neonatal hypoglycaemia and respiratory distress		48 hours after birth
neonatal need of intensive care		48 hours after birth
need of c section		day of birth

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Study Chair: Maria Lucia R Oppermann, PhD Prf, HCPA-UFRGS; Principal Investigator: Vanessa K Genro, PhD, HCPA

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: March 18, 2014
• First Posted (ESTIMATE): March 19, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 19, 2014
• Last Update Submitted That Met QC Criteria: March 18, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: metformin; gestational diabetes; glyburide; fetal growth; capillar glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin; Glyburide
• Other Study ID Numbers: OAGM-001