InfectionNCT00782665
Myometrial Biopsy for the Detection of Infection
A study testing Biopsy in people with Infection, run by The Woman's Hospital of Texas at 1 site in United States.
Trial summary
This study is designed to demonstrate that women in labor become infected without exhibiting any clinical signs or symptoms of infection. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2010
- Phase
- Interventional
- 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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients must be afebrile throughout labor.
- Amniotic fluid must be not purulent; presence of meconium is not an exclusion.
- Patients undergoing an elective cesarean section.
- Patients who have labored with intact or ruptured amniotic membranes.
Who cannot join
- Patient with a temperature of ≥ 100.4o F.
- White blood cell count ≥ 24,000.
- Suspicion of chorioamnionitis.
- Suspicion of a urinary tract infection.
- Presence of diarrhea (defined > 4 liquid stools in a 24 hour period).
- Patient currently taking therapeutic antibiotics.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Woman's Hospital of Texas
Houston, Texas, 77054
Donna Roth, BA, 713-791-7129, Donna.Roth@HCAhealthcare.com
Sebastian Faro, MD, PhD
About this study
This study is designed to demonstrate that women in labor become infected without exhibiting any clinical signs or symptoms of infection.
Read the detailed description
The infection is a dynamic process probably beginning shortly after the onset of labor. This process continues and is enhanced during active uterine contractions, which result in bacteria from the vagina being drawn up into the uterine cavity. During labor, bacterial colonization of the amniotic fluid, the decidua, and even the fetus can occur, resulting in infection of the mother and the fetus.
- Conditions
- Infection
- Being tested
- Biopsy
- Keywords
- postoperative, infection, c-section
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
1 centimeter x 1/2 centimeter piece cut from uterus
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patients who have labored and subsequently delivered by cesarean section Receives: Procedure: Biopsy |
| 2 | Placebo comparator | Patients who electively select cesarean section Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative infection following rupture of amniotic membranes
Measured: Amount of time it takes to obtain culture result
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Woman's Hospital of Texas
- Sponsor type
- University, hospital or other
- Investigators
- Sebastian Faro, MD, PhD, Principal investigator, The Woman's Hospital of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782665
- Sponsor's protocol ID
- 10012008Faro
- Status last verified
- Oct 2008
- First submitted
- 28 Oct 2008
- Last updated
- 31 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myometrial Biopsy for the Detection of Infection
- ClinicalTrials.gov ID
- NCT00782665
- Acronym / sponsor ID
- 10012008Faro
- Conditions
- Infection
- Keywords
- postoperative, infection, c-section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Woman's Hospital of TexasUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 31 Oct 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.
This study is designed to demonstrate that women in labor become infected without exhibiting any clinical signs or symptoms of infection.
Detailed description
The infection is a dynamic process probably beginning shortly after the onset of labor. This process continues and is enhanced during active uterine contractions, which result in bacteria from the vagina being drawn up into the uterine cavity. During labor, bacterial colonization of the amniotic fluid, the decidua, and even the fetus can occur, resulting in infection of the mother and the fetus.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: BiopsyPatients who have labored and subsequently delivered by cesarean section |
| 2 | Placebo comparator | Procedure: BiopsyPatients who electively select cesarean section |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients must be afebrile throughout labor.
- Amniotic fluid must be not purulent; presence of meconium is not an exclusion.
- Patients undergoing an elective cesarean section.
- Patients who have labored with intact or ruptured amniotic membranes.
Key exclusion criteria (6 listed)
- Patient with a temperature of ≥ 100.4o F.
- White blood cell count ≥ 24,000.
- Suspicion of chorioamnionitis.
- Suspicion of a urinary tract infection.
- Presence of diarrhea (defined > 4 liquid stools in a 24 hour period).
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 |
|---|---|---|
| Biopsy1 centimeter x 1/2 centimeter piece cut from uterus | Procedure or surgery | 2, Group 1 |
Primary outcome
Postoperative infection following rupture of amniotic membranes
Time frame: Amount of time it takes to obtain culture result
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 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.
Sebastian Faro, MD, PhD principal investigator
The Woman's Hospital of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Infection, run by The Woman's Hospital of Texas at 1 site in United States.
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 4 inclusion and 6 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 31 Oct 2008. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative infection following rupture of amniotic membranes (time frame: Amount of time it takes to obtain culture result). 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 Oct 2008.