- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00933881
Gestational Diabetes and Sleep-Disordered Breathing
July 13, 2016 updated by: Christiana Care Health Services
A Pilot Study to Evaluate the Association Between Gestational Diabetes, Heart Rate Variability and Sleep-Disordered Breathing
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Delaware
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Newark, Delaware, United States, 19713
- Christiana Care Health Services
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women with Gestational Diabetes Mellitus (GDM)
Description
Inclusion Criteria:
- Pregnant women aged 18-40 years old.
- Pregnant women at gestational age 30 to 34 weeks.
Exclusion Criteria:
- Pregnant women with known type 1 or type 2 diabetes mellitus.
- Pregnant women carrying more than one fetus.
- Pregnant women with pre-gestational hypertension.
- Pregnant women with pre-eclampsia during current pregnancy.
- Pregnant women with a history of coronary artery disease or acute ischemia.
- Pregnant women who currently smoke.
- Pregnant women without results for the 3 hour 100 gram oral glucose tolerance test.
- Pregnant women with preterm labor, cervical shortening, premature rupture of membranes or any other obstetric complications that may predispose to preterm labor.
- Pregnant women using 17-P (progesterone) to prevent recurrent pre-term labor.
- Pregnant women with known SDB.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Gestational Diabetes Mellitus (GDM)
|
Determining a change in heart rate variability post delivery of the baby
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in heart rate control post-GDM
Time Frame: Two months after delivery
|
Two months after delivery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in SDB post-GDM
Time Frame: Two months after delivery
|
Two months after delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
July 6, 2009
First Submitted That Met QC Criteria
July 6, 2009
First Posted (Estimate)
July 7, 2009
Study Record Updates
Last Update Posted (Estimate)
July 14, 2016
Last Update Submitted That Met QC Criteria
July 13, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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