Women With Minor Degrees of Glucose Intolerance and the Postpartum Glucose Tolerance Test

NCT ID: NCT03623412

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2019-09-30

Brief Summary

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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)

Detailed Description

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Conditions

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Glucose Tolerance Impaired in Pregnancy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers

Study Groups

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One abnormal value

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

Group Type EXPERIMENTAL

75g oral glucose tolerance test

Intervention Type DIAGNOSTIC_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

GDM

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

Group Type ACTIVE_COMPARATOR

75g GTT

Intervention Type DIAGNOSTIC_TEST

post-partum GTT

Interventions

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75g oral glucose tolerance 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

Intervention Type DIAGNOSTIC_TEST

75g GTT

post-partum GTT

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pre-existing diabetes, or failed to perform the OGTT
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Clalit Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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0068-18

Identifier Type: -

Identifier Source: org_study_id

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