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Gestational Diabetes and Sleep-Disordered Breathing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00933881
First Posted: July 7, 2009
Last Update Posted: July 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christiana Care Health Services
  Purpose
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.

Condition Intervention
Gestational Diabetes Mellitus Other: Determining a change in heart rate variability post delivery of the baby

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Pilot Study to Evaluate the Association Between Gestational Diabetes, Heart Rate Variability and Sleep-Disordered Breathing

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Improvement in heart rate control post-GDM [ Time Frame: Two months after delivery ]

Secondary Outcome Measures:
  • Improvement in SDB post-GDM [ Time Frame: Two months after delivery ]

Enrollment: 32
Study Start Date: November 2008
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Gestational Diabetes Mellitus (GDM) Other: Determining a change in heart rate variability post delivery of the baby
Determining a change in heart rate variability post delivery of the baby

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with Gestational Diabetes Mellitus (GDM)
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933881


Locations
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19713
Sponsors and Collaborators
Christiana Care Health Services
  More Information

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00933881     History of Changes
Other Study ID Numbers: 28143
First Submitted: July 6, 2009
First Posted: July 7, 2009
Last Update Posted: July 14, 2016
Last Verified: July 2016

Keywords provided by Christiana Care Health Services:
GDM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications