Gestational Diabetes and Sleep-Disordered Breathing

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00933881
First received: July 6, 2009
Last updated: July 15, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in SDB post-GDM [ Time Frame: Two months after delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933881

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

No publications provided

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00933881     History of Changes
Other Study ID Numbers: 28143
Study First Received: July 6, 2009
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014