NCT02409017

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 3, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

April 2, 2015

Last Update Submit

September 30, 2019

Conditions

DiabetesPregnancy

Keywords

insulin driplabor

Outcome Measures

Primary Outcomes (1)

  • Mean maternal glucose

    Labor

Study Arms (2)

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

Insulin dripPROCEDURE
Protocol AProtocol B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a. Pregnant patients with either pre-existing diabetes or gestational diabetes type A2 who require insulin for euglycemia during labor and delivery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WellSpan York Hospital

York, Pennsylvania, 17403, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 6, 2015

Study Start

April 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 3, 2019

Record last verified: 2019-09

Locations

US(1)