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Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus

Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus - Stage 2, a Multicentre Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02290860
Acronym
SoL
Enrollment
228
Registered
2014-11-14
Start date
2014-12-31
Completion date
2018-12-31
Last updated
2019-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gestational

Brief summary

Gestational diabetes mellitus (GDM) is defined as a hyperglycemia with onset or first recognition during pregnancy. GDM complicates 5 to 25% of pregnancies, depending on the diagnostic criteria used and the population being studied. GDM is an important red flag: up to 70% women with GDM will develop type 2 diabetes mellitus (T2DM) during their lifetime. Accordingly, professional associations recommend T2DM postpartum screening (T2DM-pP-S), 6-to-24 weeks after delivery. A 75g oral glucose tolerance test (OGTT) should be performed for diagnosis (gold standard). Nevertheless, this T2DM-pP-S recommendation has failed worldwide for the same reasons: the presently impractical pattern of the testing. A solution is direly needed. Our overall goal is to improve detection of pre-diabetes and diabetes and more specifically, to facilitate the recommended T2DM-pP-S in women diagnosed with GDM. We hypothesize that, in GDM women, results of an OGTT performed after delivery, before hospital discharge (OGTT-1) predict results of the recommended OGTT at 6-to-12 weeks postpartum (OGTT-2). Our aims are: 1. To validate in Caucasian women the predictive threshold value of the 2hr-glucose of OGTT-1 established by our Stage-1 study. 2. To determine, in a multiethnic non-Caucasian cohort, the threshold value for the 2hr-glucose of OGTT-1 that is predictive of abnormal glucose tolerance at OGTT-2. 3. To define the OGTT time preference of women (before hospital discharge vs. 6-to-12 weeks postpartum). If our results are in line with our Stage-1 data, most redundant 6-to-24 weeks postpartum OGTT will be avoided. Medical practice will change.

Interventions

PROCEDUREType 2 diabetes diagnosis test

Participants will perform type 2 diabetes diagnosis test the day of hospital discharge after delivery and the same test around 8 weeks later.

Sponsors

University of Toronto
CollaboratorOTHER
University of Manitoba
CollaboratorOTHER
Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Women aged between 18 and 45 years; * Having a positive diagnosis of gestational diabetes mellitus (GDM) (IADPSG or CDA criteria or patient followed for GDM); * Treated with diet, insulin or oral hypoglycemic agents; * Have given birth to a child at term (gestational age ≥ 37 weeks); * Have signed the consent form.

Exclusion criteria

* History of glucose intolerance or diabetes before the pregnancy; * Have presented another obstetrical pathology during the pregnancy; * Severe gestational high blood pressure with proteinuria; * Delayed intrauterine development syndrome; * Pregnancy with more than a foetus; * Drug addiction; * Had complications during the delivery such as: * Moderate to severe postpartum bleeding; * Surgery in postpartum (curettage, hysterectomy, etc.).

Design outcomes

Primary

MeasureTime frame
abnormal glucose tolerance8 weeks after delivery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026