Gestational Diabetes and Sleep-Disordered Breathing

Gestational Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933881
• Other study ID #: 28143
• Status: Completed
• Phase: N/A
• First received: July 6, 2009
• Last updated: July 13, 2016
• Start date: November 2008
• Est. completion date: February 2016

Study information

• Verified date: July 2016
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Christiana Care Health Services	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in heart rate control post-GDM		Two months after delivery	No
Secondary	Improvement in SDB post-GDM		Two months after delivery	No