Oral Antidiabetic Agents in Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT02091336
First received: February 25, 2014
Last updated: March 18, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Gestational Diabetes
Drug: Metformin
Drug: Glyburide
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
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)
Arms Assigned Interventions
Active Comparator: Glyburide
Glyburide 2,5 mg
Drug: Glyburide
patients treatment
Other Name: Glibenclamida, Glucovance
Active Comparator: Metformin
Metformin 500mg bid
Drug: Metformin
patients treatment
Other Name: Glucophage, Glifage

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02091336

Contacts
Contact: Maria Lucia R Oppermann, PhD 55 51 33598117 maluopp@gmail.com
Contact: Vanessa K Genro, PhD 55 51 81313734 vanessagenro@gmail.com

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Chair: Maria Lucia R Oppermann, PhD Prf HCPA-UFRGS
Principal Investigator: Vanessa K Genro, PhD HCPA
  More Information

No publications provided

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02091336     History of Changes
Other Study ID Numbers: OAGM-001
Study First Received: February 25, 2014
Last Updated: March 18, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital de Clinicas de Porto Alegre:
gestational diabetes
metformin
glyburide
fetal growth
capillar glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Glyburide
Hypoglycemic Agents
Metformin
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014