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

Christiana Care Health Services1 site in 1 country32 target enrollmentNovember 2008

ConditionsGestational Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gestational Diabetes Mellitus
Sponsor: Christiana Care Health Services
Enrollment: 32
Locations: 1
Primary Endpoint: Improvement in heart rate control post-GDM
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

February 2016

Last Updated

9 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Christiana Care Health Services

Responsible Party

Sponsor

Eligibility Criteria

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.