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Utility Of Hemoglobin A1C For The Diagnosis Of Gestational Diabetes (A1cGDM)

26. november 2018 oppdatert av: Mike O'Callaghan Military Hospital

Utility Of Hemoglobin A1C (HbA1C) For The Diagnosis Of Gestational Diabetes Mellitus (GDM).

A prospective cohort research study is being conducted in the Mike O'Callaghan Federal Medical Center (MOFMC), Department of Family Medicine, Obstetrics Clinic to determine if early screening with hemoglobin A1C, a blood test for blood glucose, can be used to identify women with hyperglycemia or Gestational Diabetes Mellitus (GDM) in the first semester of pregnancy in place of a fasting blood glucose blood test. This study will also determine how hemoglobin A1C compares with the oral glucose tolerance test (GTT) done as a standard of care with the standard of care second trimester prenatal care testing. Subjects recruited and consented during the Obstetrics Orientation Class will have two (2) additional blood tests drawn with their standard of care prenatal tests in the first trimester (<13 weeks) of pregnancy and at the second trimester (24-28 weeks) of pregnancy. Subjects identified as having GDM by blood HbA1C, fasting glucose or the 2 hr OGTT will be treated for GDM with standard of care by their primary care provider. The correlation of blood HbA1C with the fasting glucose in the first trimester of pregnancy and with the 2 hr OGTT will be determined for early detection and diagnosis of GDM. This study will contribute to understanding the role of HbA1C in pregnancy and the development of GDM.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

This is a prospective cohort research study conducted in the Mike O'Callaghan Federal Medical Center (MOFMC), Department of Family Medicine Residency and Obstetrics Clinics. Subjects will be pregnant female active duty or DoD beneficiaries 18 years or older recruited from the MOFMC, Department of Family Medicine Residency Clinic, and Obstetrics Orientation Class at Nellis AFB. At the screening, the Research Assistant discusses the study, answers all questions, obtains Informed Consent, and schedules appointments for routine OB care. The research design includes a screening visit to obtain written consent and two (2) additional laboratory blood tests obtained during the standard of care prenatal screen testing during the first and second trimesters of pregnancy. Each laboratory blood test will be done via 1 venipuncture for 5-10 ml (1-2 teaspoons) of blood. The OB nurse orders all labs upon completion of the Obstetrics Orientation Class.

Screening Visit: Initial Standard of Care Obstetrics Appointment

  • Obtain subject signed Informed Consent document and HIPAA Authorization
  • Demographic data: age, race, weight, height, estimated week of gestation
  • Review past medical history

First Trimester Prenatal Visit (<13 weeks) Screen Testing

  • Subjects will have routine prenatal labs drawn to include the HbA1C blood test which is standard of care
  • Subjects will have fasting (10 hour) glucose blood test will be ordered along with these labs (research driven)

Second Trimester Prenatal Visit (24-28 weeks)

  • Subjects will have routine prenatal labs drawn to include the 2 hr glucose tolerance test (2 hr OGTT) which is standard of care
  • Subjects will have will be the HbA1C blood test ordered along with these labs (research driven)

Delivery and Neonatal Data Collection

-Select data regarding delivery and neonatal health will be tracked. All of this data is already routinely collected as standard of care and will be found in the patient record. This will require no interaction with the patient or the neonate

Studietype

Observasjonsmessig

Registrering (Faktiske)

643

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Nevada
      • Nellis Air Force Base, Nevada, Forente stater, 89191
        • Mike O'Callaghan Federal Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Active duty or DoD beneficiaries of childbearing age 18 years or older with a positive pregnancy test

Beskrivelse

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion:

  • Active duty or DoD beneficiaries of childbearing age 18 years or older with a positive pregnancy test (beta human chorionic gonadotropin).

Exclusion:

  • Active duty or DoD beneficiaries of childbearing age 18 years or older with a positive pregnancy test (beta human chorionic gonadotropin) known to have and/or develop during the study any of the following upon review of their medical record:

    • Hemoglobinopathy (including sickle cell disease or trait, thalassemia)
    • Chronic kidney disease
    • Diabetes
  • Active duty or DoD beneficiaries of childbearing age 18 years or older with a positive pregnancy test (beta human chorionic gonadotropin) taking any of the following:
  • Erythropoietin
  • Daily oral steroids

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Case-Control
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Pregnant Women
Pregnant Women in the first trimester (<13 weeks) of pregnancy and the second trimester of pregnancy.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Fasting Glucose will be obtained during the first trimester of pregnancy
Tidsramme: 13 weeks
13 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Hemoglobin A1c will be obtained during the second trimester of pregnancy (between 24-28 weeks)
Tidsramme: 24-28 weeks
24-28 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mike O'Callaghan Military Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. oktober 2014

Primær fullføring (Faktiske)

1. juli 2017

Studiet fullført (Faktiske)

1. juli 2017

Datoer for studieregistrering

Først innsendt

14. oktober 2014

Først innsendt som oppfylte QC-kriteriene

22. oktober 2014

Først lagt ut (Anslag)

23. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. november 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. november 2018

Sist bekreftet

1. november 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FWH20130041H

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

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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