Evaluating for Type-2 Diabetes in the Very Early Postpartum Period

Diabetes Mellitus Clinical Trial

Official title:

Evaluating for Type-2 Diabetes in the Very Early Post-Partum Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988987
• Other study ID #: WUH 12318
• Secondary ID: 18-01705
• Status: Completed
• Start date: February 22, 2013
• Est. completion date: November 30, 2018

Study information

• Verified date: January 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pregnancy-associated diabetes, known as gestational diabetes mellitus (GDM), is associated with an increased lifetime risk of developing diabetes mellitus (DM) or pre-diabetes. Up to 30% of women with GDM will continue have abnormal blood glucose tests 6 or more weeks after delivery. Early diagnosis and treatment of continued impaired glucose metabolism or DM is essential because serious health problems can result.

Current guidelines recommend a 75-gram, 2-hour glucose tolerance test (GTT) 6 or more weeks after delivery for women diagnosed with GDM in order to identify those with continued DM or impaired glucose metabolism. However, approximately half of these women do not get glucose testing after delivery. The ability to test women while they are still hospitalized after having a baby could greatly increase diagnosis, care and treatment of women with abnormal glucose metabolism.

Our objective is to determine if a 75-gram, 2-hour GTT administered to women with GDM two to four days after delivery can identify those who will have an abnormal GTT at 6-12 weeks after delivery.

Description:

This will be a prospective cohort study conducted at Winthrop-University Hospital. Women 18 years old or older who delivered a child or fetus within the previous 4 days at either hospital who also were diagnosed with GDM during the pregnancy will be eligible for participation. Women will be excluded if they have issues that would interfere with administration of a GTT, are unable /unwilling to provide informed consent, or cannot follow up. Anticipated enrollment will be 250 women at each study site.

While still hospitalized two to four days postpartum, subjects will undergo a 75-gram, 2-hour GTT and have blood tested for hemoglobin A1c and glucose levels. They will be reminded to do the recommended GTT 6-12 weeks after delivery. Maternal, neonatal, and obstetric characteristics will be collected, including the any GTT results. The results of the in-hospital GTT will be compared to the result of the GTT taken 6-12 weeks postpartum and tested for correlation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women 18 years old or older

• Delivered a child or fetus within the previous 4 days

• Diagnosed with gestational diabetes during the pregnancy

Exclusion Criteria:

• Unable or unwilling to provide informed consent for the study

• Unable to undergo or complete a 2-hour oral glucose tolerance test 2-4 days postpartum

• Unable or unwilling to have study follow up.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Glucose Metabolism Disorders
• Metabolic Diseases
• Prediabetic State

Intervention

Other:
• Inpatient Postpartum GTT
Women with gestational diabetes will undergo a 75 gram, 2 hour, oral glucose tolerance test 2-4 days postpartum prior to hospital discharge, in addition to undergoing the standard of care, outpatient glucose tolerance test performed 6-12 weeks postpartum

Locations

Country	Name	City	State
United States	NYU Winthrop Hospital	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Result of an early postpartum 75-gram oral glucose tolerance test (GTT) result	The GTT result obtained 2-4 days postpartum will be compared to the GTT result obtained 6-12 weeks postpartum using the McNemar test for paired proportions.	2-4 days postpartum
Secondary	Result of a postpartum 75-gram oral glucose tolerance test (GTT)	The GTT result obtained 2-4 days postpartum will be compared to the GTT result obtained 6-12 weeks postpartum using the McNemar test for paired proportions.	6 weeks-6 months postpartum