NCT03028259

Brief Summary

A retrospective data review of 243 pregnant women (≤32 wks gestational age), dtat collected prior to 5/18/2014, with GDM, or T2DM, and their infants (until discharge from the hospital, typically up to 1 week after deliver) will be conducted. These women are of any age and all ethnic backgrounds delivering at St. Mary's Health Center.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Status
completed

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

June 5, 2014

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

19 days

First QC Date

January 10, 2017

Last Update Submit

May 14, 2018

Conditions

Glucose Variability

Outcome Measures

Primary Outcomes (1)

  • glucose levels

    the effect of glucose variability on maternal and neonatal outcomes in the obese diabetic patient.

    1 year

Study Arms (1)

lab results

monitoring of

Other: lab results

Interventions

lab resultsOTHER

Comparison of lab results

lab results

Eligibility Criteria

Age14 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Women with diabetes in pregnancy of any age, any ethnic background

You may qualify if:

  • Women with diabetes in pregnancy of any age, any ethnic background who deliver at St. Mary's Health Center, 1/1/2000 to 5/18/2014.

You may not qualify if:

  • Data collected ager 5/18/2014

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Laura Vricella, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 23, 2017

Study Start

June 5, 2014

Primary Completion

June 24, 2014

Study Completion

June 24, 2014

Last Updated

May 15, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share