NCT07293715 Permissive Versus Strict Intrapartum Glucose Management in Type 1 and Type 2 Diabetes (PRISM)
| NCT ID | NCT07293715 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ohio State University |
| Condition | Pregnancy, High Risk |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2026-02-25 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 44 participants in total. It began in 2026-02-25 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
PRISM is a single center non-inferiority randomized controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with pregestational diabetes using hybrid closed loop therapy (HCL) who are admitted for labor management. Participants will be randomized in a 1:1 fashion to one of two intrapartum glycemic control options: permissive (70-140 mg/dL) or strict (70-110 mg/dL). The primary aim of this trial it to demonstrate that permissive intrapartum glucose management is not associated with an increased risk of neonatal dysglycemia compared with strict intrapartum glucose management.
Eligibility Criteria
Inclusion Criteria * Pregnant individuals * ≥ 18 years old * Type 1 and Type 2 diabetes * Intention for vaginal delivery and admitted to Labor and Delivery * Singleton, non-anomalous fetus * Gestational age greater than or equal to 35 weeks gestation. * Cervical dilation is less than 6 cm. * Delivering at the study institution Exclusion criteria: * Scheduled cesarean delivery * Cervical dilation ≥ 6 cm on presentation to L\&D * Receipt of antenatal corticosteroids within 7 days of randomization * Fetal demise * Major fetal anomaly (attached) * Multiple gestation * Non-English speaking
Contact & Investigator
Anna Brewton, MD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT07293715 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnancy, High Risk. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07293715 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07293715 currently recruiting?
Yes, NCT07293715 is actively recruiting participants. Contact the research team at Anna.Brewton@osumc.edu for enrollment information.
Where is the NCT07293715 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT07293715 clinical trial?
NCT07293715 is sponsored by Ohio State University. The principal investigator is Anna Brewton, MD at Ohio State University. The trial plans to enroll 44 participants.