Efficacy of Treatment for Gestational Diabetes Diagnosed by the IADPSG Criteria.

NCT02708758 | Unknown DMC

• 2 other identifiers: CONACYT 233634212250-3402-10102-02-14
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

There is a lack of international uniformity in the approach to the screening and diagnosis of gestational diabetes mellitus (GDM). The new diagnostic criteria by the International Association of Diabetes and Pregnancy Study Groups (IADPSG) based on data from the study of Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) have created controversy because of the lack of clinical evidence of treatment benefit for mild GDM and the treatment effects on perinatal outcomes. The purpose of the present study is to know the efficacy of treatment to reduce adverse pregnancy outcomes in Mexican women diagnosed with GDM by IADPSG criteria.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• incidence of large for gestational age

  Sex specific birth weight for gestational age above the 90th percentile of Mexican fetal growth curves.

  obstetrical resolution (birth)

Secondary Outcomes (2)

• incidence of preeclampsia

  from 20 weeks of gestation to birth

• incidence of cesarean section

  from 26 weeks of gestation to birth

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Medical nutrition therapy plus self monitoring capillary glucose levels and if necessary drug therapy (metformin or insulin) when goals are not met.

Behavioral: Medical Nutrition Therapy

Routine care group

NO INTERVENTION

Prenatal routine care without medical nutrition therapy and without self monitoring capillary glucose levels and drug therapy specific for GDM.

Interventions

Medical Nutrition Therapy BEHAVIORAL

individualized medical nutrition therapy from a qualified nutritionist which took into consideration a woman's pre-pregnancy weight, activity level, dietary intake and weight gain, instructions on how to self- monitoring capillary glucose levels two to four times daily until the levels had been in the recommended range (fasting glucose levels no more than 95 mg/dL and 1 hour postprandial less than 140 mg/dL). Drug therapy will begin with metformin or insulin when capillary glucose levels are not met the recommended levels after at least two weeks of treatment.

Treatment group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy between 18-30 week´s gestation
• g oral glucose-tolerance test at 20-30 week´s gestation with only one altered value between: Fasting 92-99 mg/dL
• hour 180-211 mg/dL
• hour 153-177 mg/dL

You may not qualify if:

• Pregestational diabetes (first diagnosed in pregnancy) defined by altered values during 75-g oral glucose-tolerance test above:
• Fasting \>126 mg/dL 2 hour \>200 mg/dL
• Two or more altered values during oral glucose tolerance test above: Fasting 92 mg/dL
• hour 180 mg/dL
• hour 153 mg/dL
• Multiple pregnancy
• Active chronic systemic disease as hyperthyroidism, hearth, hepatic or renal disease, immunological disease as lupus and chronic hypertension

Sponsors & Collaborators

• Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes: lead

Study Sites (1)

Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

Mexico City, 11000, Mexico

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Enrique Reyes-Muñoz, MD, PhD.

  Department of Endocrinology (INPer)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrique Reyes-Muñoz, MD. PhD

CONTACT

+525555209900; dr.enriquereyes@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher in Medical Sciences

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 15, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

ME (1)