Gestational Diabetes and Sleep-Disordered Breathing

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00933881

Enrollment

Registered

2009-07-07

Start date

2008-11-30

Completion date

2016-02-29

Last updated

2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus

Keywords

GDM

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.

Interventions

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

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

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Improvement in heart rate control post-GDM	Two months after delivery

Secondary

Measure	Time frame
Improvement in SDB post-GDM	Two months after delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026