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Clinical Trials/NCT02409017
NCT02409017TerminatedNot Applicable

A Comparison of Insulin Drip Protocols in Labor: A Randomized Trial

WellSpan Health1 site in 1 country20 target enrollmentStarted: April 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tara L. Moore

Investigator

WellSpan Health

Study Sites (1)

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