Status:
UNKNOWN
Efficacy of Two Schemes of Self-monitoring Capillary Glucose in Gestational Diabetes
Lead Sponsor:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Gestational diabetes mellitus (GDM) affects 10 % of women who receive prenatal care at Instituto Nacional de Perinatología (Mexico, City). Currently, there is clear evidence on the utility of self- mo...
Detailed Description
Currently, the evidence from randomized clinical trials about the most appropriate scheme of SMGC for monitoring the glycemic control among women with GDM is limited. This study was designed to evalua...
Eligibility Criteria
Inclusion
- GDM diagnosis, defined by 2 or more altered values during oral glucose tolerance test (75g-2h): Fasting ≥ 95 mg/dl, 1 hour ≥ 180 mg/dl and 2 hours ≥ 155 mg/dl.
- Singleton pregnancy between 12-32 weeks of gestation at GDM diagnosis.
Exclusion
- Multiple pregnancy.
- Pregestational diabetes.
- Fasting glucose \> 126 mg/dl or random glucose \> 200 mg/dl before 12 weeks of gestation.
- Active pathology: systemic lupus erythematosus, rheumatoid arthritis, congenital or acquired cardiopathy, uterine leiomyoma \> 10cm, renal insufficiency and chronic hypertension.
Key Trial Info
Start Date :
December 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03769701
Start Date
December 7 2018
End Date
July 30 2022
Last Update
December 28 2021
Active Locations (1)
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1
National Institute of Perinatology
México, Mexico, 11000