Intra-amniotic InfectionPPROMNCT00701350
Biomarkers of Intra-amniotic Infection in Women With Preterm Premature Ruptured Amniotic Membranes
An observational study of Intra-amniotic Infection and Preterm Birth, run by ProteoGenix, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to investigate the expression of protein biomarkers in cervical vaginal fluid in women with preterm premature rupture of membranes (PPROM) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intra-amniotic Infection, Preterm Birth
- How many people
- 79 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2008to Feb 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women within the target gestational age range presenting to labor and delivery wards with documented rupture of amniotic membranes no greater than 24 hours duration.
Who may be able to join
- Subject is 18 years of age or older
- Subject has singleton gestation
- Subject has fetus with getstational age of at least 23 0/7 days and no greater than 33 6/7 days
- Subject has diagnosis of preterm premature rupture of amniotic membranes as determined by at least two of the following:
- Postive pooling,
- Presence of ferning from cervical vaginal fluid swab on an air dried slide,
Show all 17Show fewer
- Postivie nitrizine pH test, or, in lieu of the criteria listed above
- Positive Amnisure test result
- Positive indigo carmine egress vaginally following instillation at amniocentesis
- Subject is enrolled and has an amniocentesis within 24 hours of membrane rupture
- Subject is a candidate for expectant management as evidenced by the following:
- Absence of labor (defined by absence of painful uterine contractions)
- No clinical signs of infection (maternal fever of 37.9 C or greater, fetal heart rate greater than 160 bpm, uterine tenderness, purulent aminorrhea)
- presence of non-reassuring heart tracing
- Subject is a candidate for amniocentesis as evidenced by the following:
- Ultrasound reveals pocket of fluid likely to result in successful amniocentesis
- Physician believes that the subject shoudl undergo amniocentesis as part of their routine evaluation of their current problem of PPROM to rule out infection and/or to test for lung maturity
Who cannot join
- Subject has a fetus with major fetal anomaly (life threatening or requires surgical intervention) or chromosomal aneuploidy
- Subject has pre-existing medical indication for preterm delivery (e.g., pre-eclampsia, refractory hypertension, diabetes with significant complications, active lupus)
- Subject is unable to provide informed consent
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Presbyterian St. Luke's Medical Center
Denver, Colorado, 80218
Banner Good Samaritan Hospital
Phoenix, Arizona, 85006
Good Samaritan Hospital
San Jose, California, 95008
Tucson Medical Center
Tucson, Arizona, 85712
About this study
Official title: Identification of Proteomic Markers of Intra-amniotic Infection (IAI) in Patients With Preterm Premature Rupture of Amniotic Membranes (PPROM)
The purpose of this study is to investigate the expression of protein biomarkers in cervical vaginal fluid in women with preterm premature rupture of membranes (PPROM)
Read the detailed description
Preterm premature rupture of the membranes (PPROM) prior to 37 weeks of gestation occurs in approximately 3% of all pregnancies and is associated with one-third of all preterm births (Mercer, 2003). While there are multiple possible etiologies of PPROM, intra-amniotic infection has been implicated as a major contributor, especially at early gestational ages where fetal and neonatal adverse sequelae are frequent (Yoon, et al. 2000). Micro-organisms are recovered from the amniotic fluid obtained by trans-abdominal amniocentesis in 25-40% of women at the time of presentation with PPROM (Simhan and Canavan 2005).
Significant risks to the fetus following PPROM include both complications related to prematurity and to infection or inflammation (ACOG Practice Bulletin 2007). Complications related to prematurity include respiratory distress, intraventricular hemorrhage, and necrotizing enterocolitis. IAI, both clinically apparent and occult, is an important and potentially preventable cause of cerebral white matter injury and cerebral palsy. Ideally, an early diagnosis of IAI in the setting of PPROM is important to allow timely treatment and intervention. Amniocentesis is successful from 40 - 72% of the time with PPROM (Garite, 1982, Blackwell and Berry, 1999). Despite the accuracy for determining infection and the feasibility of amniocentesis, the vast majority of clinicians are reluctant and/or unwilling to perform this procedure in this clinical setting (Capeless and Mead, (1987). There is therefore a critical need for a noninvasive test to identify patients with IAI and PPROM. Timely identification of these sub-clinically infected patients is critical in designing rationale and efficacious treatment strategies that may reduce the fetal and neonatal sequelae associated with PPROM.
- Conditions
- Intra-amniotic Infection, Preterm Birth
- Keywords
- Pregnancy, Intra-amniotic Infection, Preterm Birth, Preterm Premature Rupture of Membranes
- Medical subject headings
- Premature Birth, Preterm Premature Rupture of the Membranes
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 | Women presenting with preterm gestation and ruptured membranes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of protein biomarkers in cervial vaginal fluid
Measured: 24 hours of amniotic membrane rupture to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-amniotic 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProteoGenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Obstetrix Medical Group
- Investigators
- Richard Porecco, MD, Principal investigator, Obstetrix Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701350
- Sponsor's protocol ID
- PGX03-OBX0009
- Acronym
- PPROM
- Status last verified
- Jul 2010
- First submitted
- 13 Jun 2008
- Last updated
- 21 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Proteomic Markers of Intra-amniotic Infection (IAI) in Patients With Preterm Premature Rupture of Amniotic Membranes (PPROM)
- ClinicalTrials.gov ID
- NCT00701350
- Acronym / sponsor ID
- PPROM / PGX03-OBX0009
- Conditions
- Intra-amniotic Infection, Preterm Birth
- Keywords
- Pregnancy, Intra-amniotic Infection, Preterm Birth, Preterm Premature Rupture of Membranes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- ProteoGenix, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Obstetrix Medical Group
- Study start
- Jun 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Jun 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.
The purpose of this study is to investigate the expression of protein biomarkers in cervical vaginal fluid in women with preterm premature rupture of membranes (PPROM)
Detailed description
Preterm premature rupture of the membranes (PPROM) prior to 37 weeks of gestation occurs in approximately 3% of all pregnancies and is associated with one-third of all preterm births (Mercer, 2003). While there are multiple possible etiologies of PPROM, intra-amniotic infection has been implicated as a major contributor, especially at early gestational ages where fetal and neonatal adverse sequelae are frequent (Yoon, et al. 2000). Micro-organisms are recovered from the amniotic fluid obtained by trans-abdominal amniocentesis in 25-40% of women at the time of presentation with PPROM (Simhan and Canavan 2005).
Significant risks to the fetus following PPROM include both complications related to prematurity and to infection or inflammation (ACOG Practice Bulletin 2007). Complications related to prematurity include respiratory distress, intraventricular hemorrhage, and necrotizing enterocolitis. IAI, both clinically apparent and occult, is an important and potentially preventable cause of cerebral white matter injury and cerebral palsy. Ideally, an early diagnosis of IAI in the setting of PPROM is important to allow timely treatment and intervention. Amniocentesis is successful from 40 - 72% of the time with PPROM (Garite, 1982, Blackwell and Berry, 1999). Despite the accuracy for determining infection and the feasibility of amniocentesis, the vast majority of clinicians are reluctant and/or unwilling to perform this procedure in this clinical setting (Capeless and Mead, (1987). There is therefore a critical need for a noninvasive test to identify patients with IAI and PPROM. Timely identification of these sub-clinically infected patients is critical in designing rationale and efficacious treatment strategies that may reduce the fetal and neonatal sequelae associated with PPROM.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Women presenting with preterm gestation and ruptured membranes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women within the target gestational age range presenting to labor and delivery wards with documented rupture of amniotic membranes no greater than 24 hours duration.
Key inclusion criteria (17 listed)
- Subject is 18 years of age or older
- Subject has singleton gestation
- Subject has fetus with getstational age of at least 23 0/7 days and no greater than 33 6/7 days
- Subject has diagnosis of preterm premature rupture of amniotic membranes as determined by at least two of the following:
- Subject is enrolled and has an amniocentesis within 24 hours of membrane rupture
Key exclusion criteria (3 listed)
- Subject has a fetus with major fetal anomaly (life threatening or requires surgical intervention) or chromosomal aneuploidy
- Subject has pre-existing medical indication for preterm delivery (e.g., pre-eclampsia, refractory hypertension, diabetes with significant complications, active lupus)
- Subject is unable to provide informed consent
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
Expression of protein biomarkers in cervial vaginal fluid
Time frame: 24 hours of amniotic membrane rupture to 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 21 Jul 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.
Richard Porecco, MD principal investigator
Obstetrix Medical Group
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-amniotic Infection and Preterm Birth, run by ProteoGenix, Inc. at 4 sites 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 17 inclusion and 3 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 21 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
Expression of protein biomarkers in cervial vaginal fluid (time frame: 24 hours of amniotic membrane rupture to 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 21 Jul 2010.