Repeat Late GDM Testing and Cesarean Delivery Rates
Impact of Late Gestational Diabetes Detection and Treatment on Cesarean Delivery Rates After Negative Initial Screening
The goal of this randomized trial is determine if re-testing for gestational diabetes in the third trimester after an ultrasound measurement of estimated fetal weight (EFW) or abdominal circumference greater than 90%ile decreases cesarean delivery rate, and to evaluate the optimal method of re-testing. The main question it aims to answer is:
Does repeat testing for gestational diabetes and management of hyperglycemia decrease the cesarean delivery rate in fetuses measuring >90%ile by estimated fetal weight (EFW) or abdominal circumference (AC) on ultrasound in the third trimester.
Participants will be randomized into two groups: Group 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM) and group 2 will have no intervention. Participants in group 1 will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This will be a prospective randomized control trial to determine if re-testing for gestational diabetes in the third trimester after an ultrasound measurement of estimated fetal weight (EFW) or abdominal circumference greater than 90%ile decreases cesarean delivery rate, and to evaluate the optimal method of re-testing. Pregnant women will be recruited with gestational age between 30 weeks and 36 weeks gestation with an ultrasound that demonstrates a fetus with either estimated fetal weight (EFW) >90%, abdominal circumference (AC)>90% or both. They will be randomized into two groups: Group 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM) and group 2 will have no intervention. Participants in group 1 will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes.
The primary outcome is cesarean delivery. Labor course, complications, and delivery/neonatal data will be obtained.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Rebecca Bradley, DO
- Telefonnummer: 973-862-5262
- E-mail: rlb310@njms.rutgers.edu
Undersøgelse Kontakt Backup
- Navn: Shauna Williams, MD
- Telefonnummer: 973-972-5262
- E-mail: williash@njms.rutgers.edu
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Gestational age 30 weeks 0 days and 36 weeks 6 days
- Ultrasound with estimated fetal weight or abdominal circumference greater than 90th%ile
- Age 18-50 years old.
Exclusion Criteria:
- Previously diagnosed gestational diabetes or pre-gestational diabetes
- Multiple gestation
- Previous cesarean delivery
- Any condition precluding vaginal delivery (placenta previa/placenta accreta spectrum disorders, vasa previa, prior uterine surgery with contraindication to vaginal delivery)
- Suboptimal dating (based on US >22wk gestation)
- Contraindication to glucose tolerance test
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Kontrolgruppe
|
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Eksperimentel: Repeat glucose tolerance test (GTT) with continuous glucose monitor
Group 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM).
Patients will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes.
The CGM sensor will collect glycemic data over 10 consecutive days, with up to 20 days of CGM data per patient, ie they will wear two 10-day CGMs in total.
The patients in group 1, as well as the researchers and the patient's provider will know the patient is wearing a CGM, however the CGM data will be blinded until the patient delivers.
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|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Rate of cesarean delivery
Tidsramme: From enrollment until delivery
|
From enrollment until delivery
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Shauna Williams, MD, Rutgers Health New Jersey Medical School
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro2026000906
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Graviditet
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King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekrutteringCirrhose, lever | HELLP syndrom | Intrahepatisk kolestase af graviditet | Graviditetssygdom | AFLP - Acute Fatty Lever of PregnancyDet Forenede Kongerige
Kliniske forsøg med Glucose tolerance test and continuous glucose monitor
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University of EdinburghNHS LothianAfsluttet