Oral Antidiabetic Agents in Pregnancy

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02091336
• Other study ID #: OAGM-001
• Status: Recruiting
• Phase: Phase 4
• First received: February 25, 2014
• Last updated: March 18, 2014
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2014
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Maria Lucia R Oppermann, PhD
• Phone: 55 51 33598117
• Email: maluopp[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Drug:
• Metformin
patients treatment
• Glyburide
patients treatment

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	hypoglycaemia	medications will be suspended if patients present with repeated hypoglycaemia	up to 9 months	No
Other	maternal weight gain		up to 9 months	No
Other	neonatal 5th minute apgar		5 minutes after birth	No
Other	neonatal hypoglycaemia and respiratory distress		48 hours after birth	No
Other	neonatal need of intensive care		48 hours after birth	No
Other	need of c section		day of birth	No
Primary	fetal growth	fetal growth will be assessed every 3 weeks by obstetric ultrasound during pregnancy until delivery	up to 9 months	No
Secondary	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	No