NCT02409017TerminatedNot Applicable
A Comparison of Insulin Drip Protocols in Labor: A Randomized Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- WellSpan Health
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Mean maternal glucose
Study Overview
Brief Summary
To assess which of two commonly utilized insulin drip protocols has better outcomes when used during the labor process.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •a. Pregnant patients with either pre-existing diabetes or gestational diabetes type A2 who require insulin for euglycemia during labor and delivery
Exclusion Criteria
- •a. Those patients who decline participation
- •b. Patients less than age 18 at the time of enrollment will be excluded to protect this vulnerable patient population c. Those patients who cannot be consented d. Patients scheduled for cesarean delivery
Arms & Interventions
Protocol A
Active Comparator
Our current standard during labor
Intervention: Insulin drip (Procedure)
Protocol B
Active Comparator
Another commonly accepted alternative for insulin drip management during labor
Intervention: Insulin drip (Procedure)
Outcomes
Primary Outcomes
Mean maternal glucose
Time Frame: Labor
Secondary Outcomes
No secondary outcomes reported
Investigators
Tara L. Moore
Investigator
WellSpan Health
Study Sites (1)
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