NCT02091336

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 19, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

February 25, 2014

Last Update Submit

March 18, 2014

Conditions

Gestational Diabetes

Keywords

gestational diabetesmetforminglyburidefetal growthcapillar glucose

Outcome Measures

Primary Outcomes (1)

  • fetal growth

    fetal growth will be assessed every 3 weeks by obstetric ultrasound during pregnancy until delivery

    up to 9 months

Secondary Outcomes (1)

  • insulin requirements to achieve glucose targets

    up to 9 months

Other Outcomes (6)

  • hypoglycaemia

    up to 9 months

  • maternal weight gain

    up to 9 months

  • neonatal 5th minute apgar

    5 minutes after birth

  • +3 more other outcomes

Study Arms (2)

Glyburide

ACTIVE COMPARATOR

Glyburide 2,5 mg

Drug: Glyburide

Metformin

ACTIVE COMPARATOR

Metformin 500mg bid

Drug: Metformin

Interventions

MetforminDRUG

patients treatment

Also known as: Glucophage, Glifage
Metformin
GlyburideDRUG

patients treatment

Also known as: Glibenclamida, Glucovance
Glyburide

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

MetforminGlyburideGlucovance

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsSulfonylurea CompoundsUreaAmidesSulfonesSulfur Compounds

Study Officials

  • Maria Lucia R Oppermann, PhD Prf

    HCPA-UFRGS

    STUDY CHAIR

  • Vanessa K Genro, PhD

    HCPA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Lucia R Oppermann, PhD

CONTACT

55 51 33598117maluopp@gmail.com

Vanessa K Genro, PhD

CONTACT

55 51 81313734vanessagenro@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

March 19, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2016

Last Updated

March 19, 2014

Record last verified: 2014-01

Locations

BR(1)