- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05430204
Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy
Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy:A Comparative Effectiveness Randomized Control Trial (PRECISE)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Michal Fishel Bartal, MD
- Telefonnummer: 713-500-6421
- E-post: Michal.F.Bartal@uth.tmc.edu
Studer Kontakt Backup
- Navn: Sarah Nazeer
- Telefonnummer: 713-500-6412
- E-post: Sarah.A.Nazeer@uth.tmc.edu
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- The University of Texas Health Science Center at Houston
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Ta kontakt med:
- Sarah Nazeer
- Telefonnummer: 713-500-6412
- E-post: Sarah.A.Nazeer@uth.tmc.edu
-
Ta kontakt med:
- Michal F Bartal, MD
- Telefonnummer: 713-500-6421
- E-post: Michal.F.Bartal@uth.tmc.edu
-
Underetterforsker:
- Sean Blackwell
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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:
- 24-30 weeks gestation undergoing GDM screening
Exclusion Criteria:
- Known diagnosis of Type I and II DM
- History of bariatric surgery
- Major fetal anomalies
- Unwilling to use CGM for GDM screening
- Incarcerated subjects
- History of allergic reaction to any of CGM metals or adhesives in contact with the skin
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: one-hour Glucose tolerance test (GCT)
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Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test.
1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test.
If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care.
This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider.
Participants will return transmitter at follow up visit after completion of 7 days.Group
I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.
|
Eksperimentell: CGM screening
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CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of neonates that show Composite Adverse Neonatal Outcome such as Large for gestational age(LGA)
Tidsramme: at time of birth
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LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)
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at time of birth
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Number of neonates that show Composite Adverse Neonatal Outcome such as shoulder dystocia
Tidsramme: at time of birth
|
Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered
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at time of birth
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Number of neonates that show Composite Adverse Neonatal Outcome such as birth injury
Tidsramme: at time of birth
|
Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury
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at time of birth
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Number of neonates that show Composite Adverse Neonatal Outcome such as Neonatal hypoglycemia
Tidsramme: from birth to discharge( upto 6 months from birth)
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Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy
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from birth to discharge( upto 6 months from birth)
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Number of neonates that show Composite Adverse Neonatal Outcome such as respiratory distress
Tidsramme: from birth to discharge( upto 6 months from birth)
|
Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life
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from birth to discharge( upto 6 months from birth)
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Number of fetal or neonatal deaths
Tidsramme: within 28 days of birth
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within 28 days of birth
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Feasibility as assessed by the number of participants who complete the CGM diagnostic testing
Tidsramme: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
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Number of women that use diabetic medication during pregnancy
Tidsramme: From enrollment to delivery
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diabetic medication is described as any glycemic control agent
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From enrollment to delivery
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Number of women that show Polyhydramnios during pregnancy not related to known fetal anomaly
Tidsramme: From enrollment to delivery
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From enrollment to delivery
|
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Number of women that have preterm birth
Tidsramme: at time of birth
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Pre term birth id described as delivery less than 37 weeks of gestation
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at time of birth
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Number of women that undergo induced labor
Tidsramme: at time of birth
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at time of birth
|
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Number of women that experience pregnancy induced hypertension
Tidsramme: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
|
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Number of women that experience Eclampsia: seizures
Tidsramme: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
|
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Number of women admitted due to poor glucose control
Tidsramme: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
|
|
Number of women with Primary cesarean section
Tidsramme: at time of birth
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at time of birth
|
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Number of women with Postpartum hemorrhage: defined as greater then 1000ml or need for blood transfusion
Tidsramme: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
|
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Number of women with endometritis
Tidsramme: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
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Number of women with wound complications
Tidsramme: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
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Number of women with diagnosis of type 2 diabetes during postpartum
Tidsramme: birth to 6 weeks postpartum
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birth to 6 weeks postpartum
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Number of neonates with Apgar score less than 7
Tidsramme: 5 minutes after birth
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5 minutes after birth
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Number of neonates that are admitted to the Neonatal intensive care unit (NICU)
Tidsramme: birth to discharge from NICU(upto 6 months after delivery)
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birth to discharge from NICU(upto 6 months after delivery)
|
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NICU length of stay
Tidsramme: day of NICU discharge(upto 6 months after delivery)
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day of NICU discharge(upto 6 months after delivery)
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Number of neonates with hyperbilirubinemia requiring phototherapy
Tidsramme: birth to discharge( upto 6 months from birth)
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birth to discharge( upto 6 months from birth)
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Number of neonates with need for intravenous glucose therapy
Tidsramme: birth to discharge( upto 6 months from birth)
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birth to discharge( upto 6 months from birth)
|
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Number of neonates that are Small for gestational age
Tidsramme: at time of birth
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Small for gestational age, defined as a weight below 10th percentile of the expected value according to gestational age (using the nomogram published by Duryea EL et al)
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at time of birth
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Number of participants who breastfed their babies
Tidsramme: upto 6 weeks postpartum
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upto 6 weeks postpartum
|
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Number of participants who formula fed their babies
Tidsramme: upto 6 weeks postpartum
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upto 6 weeks postpartum
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michal Fishel Bartal, MD, The University of Texas Health Science Center, Houston
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HSC-MS-22-0153
Plan for individuelle deltakerdata (IPD)
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