- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02409017
A Comparison of Insulin Drip Protocols in Labor: A Randomized Trial
September 30, 2019 updated by: Tara L. Moore, WellSpan Health
To assess which of two commonly utilized insulin drip protocols has better outcomes when used during the labor process.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
York, Pennsylvania, United States, 17403
- WellSpan York Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Protocol A
Our current standard during labor
|
|
Active Comparator: Protocol B
Another commonly accepted alternative for insulin drip management during labor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean maternal glucose
Time Frame: Labor
|
Labor
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
April 2, 2015
First Submitted That Met QC Criteria
April 2, 2015
First Posted (Estimate)
April 6, 2015
Study Record Updates
Last Update Posted (Actual)
October 3, 2019
Last Update Submitted That Met QC Criteria
September 30, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 690224-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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