Gestational Diabetes and Sleep-Disordered Breathing

Completed

• Conditions: Gestational Diabetes Mellitus
• Interventions: Other: Determining a change in heart rate variability post delivery of the baby

• Registration Number: NCT00933881
• Lead Sponsor: Christiana Care Health Services

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-07-06
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gestational Diabetes Mellitus (GDM)	Determining a change in heart rate variability post delivery of the baby	-

Primary Outcome Measures

Name	Time	Method
Improvement in heart rate control post-GDM	Two months after delivery

Secondary Outcome Measures

Name	Time	Method
Improvement in SDB post-GDM	Two months after delivery

Trial Locations

Locations (1)

Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States