Fetal and Maternal Repercussions of Gestational Diabetes After the Adoption of the Diagnostic Criteria Proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG): a Cohort Study

Gestational Diabetes: a Cohort Study



Sponsors


Source

University of Sao Paulo General Hospital

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

Gestational diabetes (GDM) is the most common hormonal complication during pregnancy. Its
occurrence implies an increased risk of maternal and fetal complications and, therefore, its
diagnosis and treatment are extremely important. Since the adoption of the new diagnostic
criteria proposed by the International Association of Diabetes and Pregnancy Study Groups
(IADPSG) in 2010, an increasing number of cases of mild hyperglycemia have demanded follow-up
and treatment. The need and benefit of treatment in these cases of mild hyperglycemia has
been discussed worldwide. Women who have been diagnosed with GDM are at increased risk for
type 2 DM in the years following gestation. Other factors (such as lipid profile, obesity,
adipokine dosage) may also be related to the repercussions of GDM on the maternal-fetal
binomial, since gestations with satisfactory glycemic control can also present complications
related to the disease and increased risk of type 2 DM in the long term. The present study
aims to investigate factors associated with the need for insulin use, the occurrence of
perinatal complications, nutritional status, physical activity and weight retention one year
after delivery and the postpartum diagnosis of type 2 DM 10 years after delivery in women
diagnosed with GDM according to the current criteria suggested by the IADPSG.

Overall Status

Enrolling by invitation

Start Date

2015-09-17

Completion Date

2030-12-01

Primary Completion Date

2030-06-01

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

Occurrence of type 2 DM after GDM
10 years

Secondary Outcome

Measure

Time Frame

Need of insulin
during pregnancy
Weight at birth
during pregnancy and delivery
Route of delivery
during pregnancy and delivery
Neonatal Hypoglycemia
during pregnancy and delivery
Obesity in the offspring
10 years
Hypertension in the offspring
10 years
Body composition
during pregnancy, 6 months postpartum and one year after delivery
Physical activity
during pregnancy , 6 months postpartum and 1 year after delivery
Eating habits
during pregnancy, 6 months postpartum and 1 year after delivery
Weight retention
during pregnancy, 6 months postpartum and 1 year after delivery
Route of delivery vs physical activity
during pregnancy and delivery
Route of delivery vs eating habits
during pregnancy and delivery
Fetal weight at birth vs physical activity
during pregnancy and delivery
Fetal weight at birth vs eating habits
during pregnancy and delivery

Number Of Groups

1

Enrollment

1400

Conditions


Eligibility

Study Pop

Patients who were diagnosed with gestational diabetes after the adoption of the diagnostic
criteria proposed by the IADPSG (June 2011) will be evaluated retrospectively and
prospectively in the high-risk prenatal outpatient clinic of the Obstetric Clinic of the
Hospital das Clínicas of the Medical School of the University of São Paulo (HCFMUSP), a
tertiary teaching hospital in Sao Paulo, Brazil.

Sampling Method

Non-Probability Sample

Criteria

Inclusion Criteria:

- single pregnancies

- absence of glucose intolerance prior to gestation (defined by prior diagnosis of
polycystic ovarian syndrome or fasting glycemia ≥100mg / dl or 2hr post-overload with
75g glucose ≥ 140mg / dL or glycated hemoglobin ≥ 5.7% previously to pregnancy)

- absence of chronic use of glucocorticoids or antiretroviral drugs for HIV virus, given
its diabetogenic effect and potential confounding

- diagnosis of GDM according to diagnostic criteria proposed by the IADPSG, namely:
initial fasting blood glucose ≥ 92mg / dL OR oral glucose tolerance test of 75g with
fasting ≥ 92mg / dL or after1h ≥ 180mg / dL or after 2h ≥ 153mg / dL

- Agreement with the informed consent term for patients who will be followed
prospectively

- Agreement with the free and informed consent term for recall and reassessment of the
patients identified in the retrospective analysis of the data

Exclusion Criteria:

- loss to follow up during pregnancy

Gender

Female

Minimum Age

N/A

Maximum Age

N/A

Healthy Volunteers

No


Location

Facility

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Sao Paulo 05403000 Brazil

Location Countries

Country

Brazil


Verification Date

2017-07-01

Lastchanged Date

2017-10-11

Firstreceived Date

2017-07-25

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

Gestational diabetes

Description

Women diagnosed with GDM according to the IADPSG criteria, either by abnormal fasting plasma glucose or by abnormal oral glucose tolerance test.


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Prospective


Study First Submitted

July 25, 2017

Study First Submitted Qc

October 4, 2017

Study First Posted

October 11, 2017

Last Update Submitted

October 11, 2017

Last Update Submitted Qc

October 11, 2017

Last Update Posted

October 12, 2017


ClinicalTrials.gov processed this data on October 12, 2017

Conditions

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Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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