Histological Placental Inflamation With or Without FeverNCT01175187
Intrapartum Fever and Histopathological Placental Findings
An observational study of Histological Placental Inflamation With or Without Fever, run by Wolfson Medical Center.
Trial summary
Intrapartum fever associated with epidural anesthesia is caused by non infectious causes therefore without histological findings Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Histological Placental Inflamation With or Without Fever
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Oct 2010
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 200 normal deliveries
Who may be able to join
- -
Who cannot join
- Patients with infectious backgroud or prilinged PROM
About this study
Intrapartum fever associated with epidural anesthesia is caused by non infectious causes therefore without histological findings
- Keywords
- evron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EPIDURAL FEVER | Not described | |
| EPIDURAL WITHOUT FEVER | Not described | |
| GROUP 1: EPIDURAL FEVER . GROUP 2 EPIDURAL WITHOUT FEVER | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startApr 2009
- Primary completionMar 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histological Placental Inflamation With or Without FeverStudies 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Investigators
- shmuel evron, md, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175187
- Sponsor's protocol ID
- 1077
- Status last verified
- Aug 2010
- First submitted
- 2 Aug 2010
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Fever and Histopathological Placental Findings
- ClinicalTrials.gov ID
- NCT01175187
- Acronym / sponsor ID
- 1077
- Keywords
- evron
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 4 Aug 2010 (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.
Intrapartum fever associated with epidural anesthesia is caused by non infectious causes therefore without histological findings
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EPIDURAL FEVER | – | – |
| EPIDURAL WITHOUT FEVER | – | – |
| GROUP 1: EPIDURAL FEVER . GROUP 2 EPIDURAL WITHOUT FEVER | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 200 normal deliveries
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Patients with infectious backgroud or prilinged PROM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
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.
shmuel evron, md principal investigator
Tel Aviv University
Questions about this trial
What is this clinical trial studying?
An observational study of Histological Placental Inflamation With or Without Fever, run by Wolfson Medical Center.
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: status not confirmed, as of the sponsor's last update on 10 Aug 2010. 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?
Results are not available in the source record.
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.
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 10 Aug 2010.