A Comparison of Insulin Drip Protocols in Labor: A Random... | NCT02409017

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

NCT02409017

Sponsor

WellSpan Health

Status

Terminated

Last Update Posted

Oct 3, 2019Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Diabetes
Pregnancy

Interventions

Insulin drip

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of time and participation in the study

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Apr 2, 2015

First Submission Date that Met QC Criteria

Apr 2, 2015

First Posted Date

Apr 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2019

Last Update Posted Date

Oct 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess which of two commonly utilized insulin drip protocols has better outcomes when used during the labor process.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Protocol A	Active Comparator	Our current standard during labor	Procedure: Insulin drip
Protocol B	Active Comparator	Another commonly accepted alternative for insulin drip management during labor	Procedure: Insulin drip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin drip	Procedure		Protocol A Protocol B

Measure	Description	Time Frame
Mean maternal glucose		Labor

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
WellSpan York Hospital		York	Pennsylvania	17403	United States

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided