- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Florida
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Tampa, Florida, Forente stater, 33606
- USF Health South Tampa Center for Advanced Healthcare
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Tampa, Florida, Forente stater, 33610
- TGH Health Park Genesis Clinic
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 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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Annen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Composite Perinatal morbidity
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maternal weight gain
Tidsramme: up to delivery
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up to delivery
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Alejandro Rodriguez, MD, University of South Florida
- Studiestol: Judette Louis, MD, MPH, University of South Florida
- Studieleder: Linda Odibo, University of South Florida
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00020026
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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