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Completed

NCT Number: NCT00933881

Gestational Diabetes 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.

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Key information

Conditions

Gestational Diabetes Mellitus Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Christiana Care Health Services

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. Improvement in heart rate control post-GDM

    Time frame: Two months after delivery

Secondary outcomes

  1. Improvement in SDB post-GDM

    Time frame: Two months after delivery

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

A Pilot Study to Evaluate the Association Between Gestational Diabetes, Heart Rate Variability and Sleep-Disordered Breathing

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Jul 7, 2009
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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