Gestational Diabetes and Sleep-Disordered Breathing

NCT ID: NCT00933881

Last Updated: 2016-07-14

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

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2016-02-29

Brief Summary

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This study is designed to evaluate the amount of heart rate variability (HRV) for women with gestational diabetes mellitus (GDM) and to determine whether women with GDM have transient sleep-disordered breathing (SDB) during pregnancy.

Detailed Description

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Conditions

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Gestational Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Gestational Diabetes Mellitus (GDM)

Determining a change in heart rate variability post delivery of the baby

Intervention Type OTHER

Determining a change in heart rate variability post delivery of the baby

Interventions

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Determining a change in heart rate variability post delivery of the baby

Determining a change in heart rate variability post delivery of the baby

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Pregnant women aged 18-40 years old.
2. Pregnant women at gestational age 30 to 34 weeks.

Exclusion Criteria

1. Pregnant women with known type 1 or type 2 diabetes mellitus.
2. Pregnant women carrying more than one fetus.
3. Pregnant women with pre-gestational hypertension.
4. Pregnant women with pre-eclampsia during current pregnancy.
5. Pregnant women with a history of coronary artery disease or acute ischemia.
6. Pregnant women who currently smoke.
7. Pregnant women without results for the 3 hour 100 gram oral glucose tolerance test.
8. Pregnant women with preterm labor, cervical shortening, premature rupture of membranes or any other obstetric complications that may predispose to preterm labor.
9. Pregnant women using 17-P (progesterone) to prevent recurrent pre-term labor.
10. Pregnant women with known SDB.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Christiana Care Health Services

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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28143

Identifier Type: -

Identifier Source: org_study_id

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