NCT03623412

Brief Summary

The aim of this study is to offer a 75g postpartum glucose tolerance test to women with minor degrees of glucose intolerance and to assess if these women are significantly different from women who were diagnosed as GDM (Gestational Diabetes Mellitus)

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Status
unknown

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

First Submitted

Initial submission to the registry

August 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

August 6, 2018

Last Update Submit

August 12, 2018

Conditions

Glucose Tolerance Impaired in Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Positive post-partum GTT results

    6-12 weeks post partum

Study Arms (2)

One abnormal value

EXPERIMENTAL

Women with only one abnormal value on OGTT (Oral Glucose Tolerance Test) during pregnancy

Diagnostic Test: 75g oral glucose tolerance test

GDM

ACTIVE COMPARATOR

Women with two abnormal values on OGTT during pregnancy - diagnosis=GDM

Diagnostic Test: 75g GTT

Interventions

75g oral glucose tolerance testDIAGNOSTIC_TEST

Women with one abnormal value in the OGTT during pregnancy (minor degree of glucose intolerance) will be offered a post-partum 75g GTT (Glucose Tolerance Test), similar to that offered to women with GDM

One abnormal value
75g GTTDIAGNOSTIC_TEST

post-partum GTT

GDM

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy women (without pre-existing diabetes) who underwent an OGTT during pregnancy

You may not qualify if:

  • pre-existing diabetes, or failed to perform the OGTT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 9, 2018

Study Start

August 15, 2018

Primary Completion

September 15, 2019

Study Completion

September 30, 2019

Last Updated

August 14, 2018

Record last verified: 2018-08