- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02377531
Early Screen and Treatment for Gestational Diabetes
Gestational Diabetes Mellitus: Does Early Screening and Treatment for Patients at Increased Risk for Gestational Diabetes Impact Perinatal Outcomes? A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Tampa, Florida, Estados Unidos, 33606
- USF Health South Tampa Center for Advanced Healthcare
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Tampa, Florida, Estados Unidos, 33610
- TGH Health Park Genesis Clinic
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Pregnant subjects 18-45 y/o and Any of the following:
Obesity defined as having a BMI>30 kg/m2 History of pregnancy complicated with GDM History of pregnancy complicated with macrosomia First degree relative with diabetes Multiple gestation
Exclusion Criteria:
- Incomplete Data: if any data is missing (i.e Delivery data) , analysis cannot be completed.
Pregnancy complicated with fetal malformations or aneuploidy: It affects prenatal care, mode of delivery as well as perinatal outcome.
Pregestational or Overt Diabetes: Patients with Diabetes cannot be diagnosed with GDM.
Chronic medical conditions such as hypertension, renal disease, autoimmune conditions: Those conditions may affect prenatal care, perinatal morbidity.
Early diabetes screen performed prior to enrollment in study: Participant cannot be randomized, and probably have been treated.
Medical contraindication to glucose tolerance test (bariatric surgery): patients with h/o gastric bypass frequently cannot tolerate oral glucose load, therefore cannot be screened for GDM in the traditional way.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: Early glucose screen group
Participants with high risk factors for gestational diabetes, will be randomly assigned to an early glucose screen group: it consists of an oral load of 50 grams of glucose followed by a measurement of serum glucose 1 hour later, and if abnormal (higher than 130mg/dl), will undergo a 100 gram oral load of glucose followed by serum glucose levels drawn 1,2 and 3 hours after the load.
If abnormal according to Carpenter-Cousant criteria, the participant will undergo standard of care for Gestational Diabetes.
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Main intervention is randomization: half of the participants will be randomized to undergo a 50 gram oral glucose load with a 1 hour serum glucose measurement as a screen for Gestational Diabetes mellitus at 12 to 18 weeks of pregnancy instead of standard 24 to 28 weeks of pregnancy
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Otro: Standard glucose screen group
The participants in this group will be randomized to undergo the testing process previously described at 24 to 28 weeks.
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Main intervention is randomization: half of the participants will be randomized to undergo a 50 gram oral glucose load with a 1 hour serum glucose measurement as a screen for Gestational Diabetes mellitus at 24 to 28 weeks of pregnancy
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Composite Perinatal morbidity
Periodo de tiempo: up to 28 days after birth
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The primary study outcome is a composite of perinatal morbidities including perinatal mortality (stillbirth or neonatal death), neonatal hypoglycemia, hyperbilirubinemia, and birth trauma.
Transcutaneous bilirubin is routinely measured at Tampa General Hospital (TGH) on all babies at least once.
A value greater than the 95th percentile for or need for phototherapy at any given point after birth will be considered an elevated level.
Birth trauma is defined as brachial plexus palsy or clavicular, humeral, or skull fracture.
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up to 28 days after birth
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Maternal weight gain
Periodo de tiempo: up to delivery
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up to delivery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alejandro Rodriguez, MD, University of South Florida
- Silla de estudio: Judette Louis, MD, MPH, University of South Florida
- Director de estudio: Linda Odibo, University of South Florida
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00020026
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .