Efficacy of Treatment for Gestational Diabetes Diagnosed by the IADPSG Criteria.
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|ClinicalTrials.gov Identifier: NCT02708758|
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes||Behavioral: Medical Nutrition Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Treatment in Women With Gestational Diabetes Mellitus Diagnosed by One Altered Value by the International Association of Diabetes and Pregnancy Study Groups Criteria (IADPSG).|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Treatment group
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
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.
No Intervention: Routine care group
Prenatal routine care without medical nutrition therapy and without self monitoring capillary glucose levels and drug therapy specific for GDM.
- incidence of large for gestational age [ Time Frame: obstetrical resolution (birth) ]Sex specific birth weight for gestational age above the 90th percentile of Mexican fetal growth curves.
- incidence of preeclampsia [ Time Frame: from 20 weeks of gestation to birth ]incidence of women at fina of gestation that have high blood pressure > 140/90 and proteinuria (more than 300 mg/dl) after 20 weeks of gestation.
- incidence of cesarean section [ Time Frame: from 26 weeks of gestation to birth ]Extraction of the fetus by means of abdominal hysterotomy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708758
|Contact: Enrique Reyes-Muñoz, MD. PhD||+525555209900 ext email@example.com|
|Instituto Nacional de Perinatología Isidro Espinosa de los Reyes||Recruiting|
|Mexico City, Mexico, 11000|
|Contact: Nayeli Martínez-Cruz, MD +525555209900 ext 299 firstname.lastname@example.org|
|Contact: Enrique Reyes-Muñoz, MD, PhD. +525555209900 ext 299 email@example.com|
|Principal Investigator:||Enrique Reyes-Muñoz, MD, PhD.||Department of Endocrinology (INPer)|