Oral Glucose Tolerance Testing After Gestational Diabetes

Completed

• Conditions: Gestational Diabetes; Pregnancy; Obesity

• Registration Number: NCT02082301
• Lead Sponsor: MetroHealth Medical Center

Brief Summary

This is an observation study of women with gestational diabetes. Subjects recruited undergo immediate postpartum diabetic screening prior to discharge. Post-partum screening for overt diabetes is repeated 6-12 weeks postpartum. The outcome of interest is the utility of an immediate post partum screen for overt diabetes compared to a traditional 6 week test.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-10
• Primary Completion: 2016-05-04
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

Inclusion Criteria

• Singleton pregnancy
• Gestational diabetes

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Exclusion Criteria

• Multiple gestations
• pre-pregnancy diabetes

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: sensitivity of immediate post partum screen	Immediate post partum	2 hour fasting 75g OGTT immediately post partum. This is compared to a traditional 6 week post partum 75g OGTT for the sensitivity, positive and negative predictive value of the immediate post partum test

Secondary Outcome Measures

Name	Time	Method
Secondary outcome: physiology	3 time points: antepatum, immediate postpartum, 6 weeks post partum	A small sub-cohort of women will undergo an additional 2 hour fasting 75g OGTT in the third trimester with measurements of insulin, cytokines, lipids.

Trial Locations

Locations (2)

University Hospital; 🇺🇸 Cleveland, Ohio, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States