Atelectasis During Delivery - Comparing Cesarian (c) -Sec... | NCT00665405

Studies
Atelectasis During Delivery - Comparing Cesarian (c) -Section and Labor

NCT00665405

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Apr 23, 2008Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Delivery, Obstetric
Cesarean Section
Labor
Respiration Disorders
Atelectasis

Interventions

CT scan

Countries

Not provided

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

Jan 2008

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

Jul 2006

Primary Completion Date

Not provided

Completion Date

Nov 2007Actual

First Submitted Date

Apr 21, 2008

First Submission Date that Met QC Criteria

Apr 21, 2008

First Posted Date

Apr 23, 2008Estimated

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

Apr 21, 2008

Last Update Posted Date

Apr 23, 2008Estimated

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

Pregnancy promotes respiratory system's restrictive component. This study observes the generation of atelectasis during labor.

Detailed Description

Pregnancy causes restriction of diaphragm movements as well as higher resistive component to the respiratory system. Spirometry studies have shown that the supine position increases risks of hypoxemia. There seems to be only casual observation regarding the generation of atelectasis during labor.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PN		Control - Induced or natural labor under anesthesia	Radiation: CT scan
PC		Case - Cesarean section under anesthesia	Radiation: CT scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT scan	Radiation	Thoracic CT scan	PC PN

Measure	Description	Time Frame
atelectasis		60-120 minutes after delivery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

post-anesthesia recovery

Exclusion Criteria:

hemodynamic disorder during labor

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Hospital, obstetric division

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joaquim E Vieira, MD, PhD	University of Sao Paulo Medical School - FMUSP	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012120	Respiration Disorders
D001261	Pulmonary Atelectasis

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided