Snoring in Pregnancy and Adverse Maternal and Fetal Outcomes | NCT01030003

Studies
Snoring in Pregnancy and Adverse Maternal and Fetal Outcomes

NCT01030003

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Mar 7, 2012Estimated

Enrollment

1,685Actual

Phase

Not provided

Conditions

Sleep Apnea Syndromes

Interventions

Not provided

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

ID	Type	Description	Link
1R21HL089918-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2012

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

Jan 2007

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Dec 8, 2009

First Submission Date that Met QC Criteria

Dec 9, 2009

First Posted Date

Dec 10, 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

Mar 6, 2012

Last Update Posted Date

Mar 7, 2012Estimated

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

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

The purpose of the study is to determine the prevalence of sleep-disordered breathing in pregnant women during the third trimester of pregnancy and to investigate whether this is associated with high blood pressure in the mother and/or growth retardation in the baby.

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

1,685Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maternal diagnosis of hypertension		0-3 months after enrollment.

Secondary Outcomes

Measure	Description	Time Frame
Infant birth centile		0-3 months after enrollment.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women attending obstetric clinics at University of Michigan Hospitals.
Willing and able to provide informed consent.
Aged 18 years or older

Exclusion Criteria:

Aged under 18 years

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Eligible pregnant women are those receiving prenatal care and planning on delivering at the University of Michigan.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Louise M O'Brien, PhD	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan		Ann Arbor	Michigan	48109	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24179294	Derived	O'Brien LM, Bullough AS, Owusu JT, Tremblay KA, Brincat CA, Chames MC, Kalbfleisch JD, Chervin RD. Snoring during pregnancy and delivery outcomes: a cohort study. Sleep. 2013 Nov 1;36(11):1625-32. doi: 10.5665/sleep.3112.

ID	Term
D012891	Sleep Apnea Syndromes
D012913	Snoring
D005317	Fetal Growth Retardation
D011225	Pre-Eclampsia

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic