Gestational Diabetes and Sleep-Disordered Breathing | NCT00933881

Studies
Gestational Diabetes and Sleep-Disordered Breathing

NCT00933881

Sponsor

Christiana Care Health Services

Status

Completed

Last Update Posted

Jul 14, 2016Estimated

Enrollment

32Actual

Phase

Not provided

Conditions

Gestational Diabetes Mellitus

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Jul 6, 2009

First Submission Date that Met QC Criteria

Jul 6, 2009

First Posted Date

Jul 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2016

Last Update Posted Date

Jul 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gestational Diabetes Mellitus (GDM)			Other: Determining a change in heart rate variability post delivery of the baby

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	Gestational Diabetes Mellitus (GDM)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Women with Gestational Diabetes Mellitus (GDM)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christiana Care Health Services		Newark	Delaware	19713	United States

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided