Delivery, ObstetricNCT00665405
Atelectasis During Delivery - Comparing Cesarian (c) -Section and Labor
An observational study of Delivery, Obstetric and Cesarean Section, run by University of Sao Paulo.
Trial summary
Pregnancy promotes respiratory system's restrictive component. This study observes the generation of atelectasis during labor. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery, Obstetric, Cesarean Section, Labor
- What is being tested?
- CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Nov 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Hospital, obstetric division
Who may be able to join
- post-anesthesia recovery
Who cannot join
- hemodynamic disorder during labor
About this study
Official title: CT Study of Atelectasis After Delivery - Comparison Between Cesarian Section and Labor
Pregnancy promotes respiratory system's restrictive component. This study observes the generation of atelectasis during labor.
Read the 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.
- Conditions
- Delivery, Obstetric, Cesarean Section, Labor, Respiration Disorders, Atelectasis
- Being tested
- CT scan
- Keywords
- Delivery, obstetric, Atelectasis
- Medical subject headings
- Respiration Disorders, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanRadiation
Thoracic CT scan
| Study group | Role | What they receive |
|---|---|---|
| PN | Control - Induced or natural labor under anesthesia Receives: Radiation: CT scan | |
| PC | Case - Cesarean section under anesthesia Receives: Radiation: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
atelectasis
Measured: 60-120 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startJul 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery, ObstetricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Joaquim E Vieira, MD, PhD, Principal investigator, University of Sao Paulo Medical School - FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665405
- Sponsor's protocol ID
- CAP649-05
- Status last verified
- Jan 2008
- First submitted
- 21 Apr 2008
- Last updated
- 23 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Study of Atelectasis After Delivery - Comparison Between Cesarian Section and Labor
- ClinicalTrials.gov ID
- NCT00665405
- Acronym / sponsor ID
- CAP649-05
- Conditions
- Delivery, Obstetric, Cesarean Section, Labor, Respiration Disorders, Atelectasis
- Keywords
- Delivery, obstetric, Atelectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PN | – | Radiation: CT scanControl - Induced or natural labor under anesthesia |
| PC | – | Radiation: CT scanCase - Cesarean section under anesthesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Hospital, obstetric division
Key inclusion criteria (1 listed)
- post-anesthesia recovery
Key exclusion criteria (1 listed)
- hemodynamic disorder during labor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanThoracic CT scan | Radiation | PC, PN |
Primary outcome
atelectasis
Time frame: 60-120 minutes after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joaquim E Vieira, MD, PhD principal investigator
University of Sao Paulo Medical School - FMUSP
Questions about this trial
What is this clinical trial studying?
An observational study of Delivery, Obstetric and Cesarean Section, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atelectasis (time frame: 60-120 minutes after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2008.