EndometritisNCT00500019
Uterine Flora During Elective and Urgent Cesarean Sections
An observational study of Endometritis, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Hypothesis: The bacterial flora of the uterus during elective Cesarean sections differs from the uterine flora during non-elective Cesarean sections. We want to study whether the uterine flora can predict post-cesarean febrile morbidity and endometritis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometritis
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2005to Sep 2008
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women undergoing cesarean sections in Western galilee Hospital
Who may be able to join
- Cesarean delivery
Who cannot join
- Vaginal delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uterine Flora During Elective and Urgent Cesarean Sections and Its Relationship to Postpartum Complications.
Hypothesis: The bacterial flora of the uterus during elective Cesarean sections differs from the uterine flora during non-elective Cesarean sections. We want to study whether the uterine flora can predict post-cesarean febrile morbidity and endometritis.
Read the detailed description
Objective: To evaluate the uterine flora at the time of elective and non-elective cesarean sections and to study the relationship to the development of postpartum fever and/or endometritis.
Methods: Eight-hundred women who will be delivered by cesarean section will be enrolled in this study. Cultures will be obtained during the surgery from the open uterine cavity after removal of the placenta. Data regarding postpartum morbidity would be collected.
- Conditions
- Endometritis
- Medical subject headings
- Endometritis
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 |
|---|---|---|
| 1. | Elective Cesarean sections | |
| 2. | Non-elective cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare bacteriological growth between elective and non-elective cesarean section
Measured: 5 years
Secondary outcomes (1)
To study the various bacteria growth in the uteri, and to compare type of bacteria to post-op morbidity
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startJan 2005
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometritisStudies 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
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Investigators
- Ido Solt, MD, Principal investigator, Western Galilee Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500019
- Sponsor's protocol ID
- 1-Bornstein
- Status last verified
- Mar 2009
- First submitted
- 11 Jul 2007
- Last updated
- 31 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Flora During Elective and Urgent Cesarean Sections and Its Relationship to Postpartum Complications.
- ClinicalTrials.gov ID
- NCT00500019
- Acronym / sponsor ID
- 1-Bornstein
- Conditions
- Endometritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Jan 2005
- Study completion
- Sep 2008 (actual)
- First posted
- 12 Jul 2007 (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.
Hypothesis: The bacterial flora of the uterus during elective Cesarean sections differs from the uterine flora during non-elective Cesarean sections. We want to study whether the uterine flora can predict post-cesarean febrile morbidity and endometritis.
Detailed description
Objective: To evaluate the uterine flora at the time of elective and non-elective cesarean sections and to study the relationship to the development of postpartum fever and/or endometritis.
Methods: Eight-hundred women who will be delivered by cesarean section will be enrolled in this study. Cultures will be obtained during the surgery from the open uterine cavity after removal of the placenta. Data regarding postpartum morbidity would be collected.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. | – | –Elective Cesarean sections |
| 2. | – | –Non-elective cesarean section |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women undergoing cesarean sections in Western galilee Hospital
Key inclusion criteria (1 listed)
- Cesarean delivery
Key exclusion criteria (1 listed)
- Vaginal delivery
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
To compare bacteriological growth between elective and non-elective cesarean section
Time frame: 5 years
1 secondary outcome
To study the various bacteria growth in the uteri, and to compare type of bacteria to post-op morbidity
Time frame: 5 years
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 31 Mar 2009.
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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.
Ido Solt, MD principal investigator
Western Galilee Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometritis, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 31 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
To compare bacteriological growth between elective and non-elective cesarean section (time frame: 5 years). 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 31 Mar 2009.