Intra-amniotic InfectionIAINCT00700219
Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes
An observational study of Intra-amniotic Infection, run by ProteoGenix, Inc. at 21 sites in United States.
Trial summary
The purpose of this study is to collect clinical specimens and corresponding clinical data to develop a non-invasive test for detection of intra-amniotic infection and prediction of preterm birth in women and intact amniotic membranes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intra-amniotic Infection
- How many people
- 900 participants
- Where
- 21 sitesUnited States
- Study dates
- Jun 2008to Sep 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 presenting to labor and delivery with signs and symptoms of preterm labor and documented intact amntiotic membranes
Who may be able to join
- Subject is greater than or equal to 18 years of age
- Subject has singleton gestation
- Subject has fetus with gestational age greater than or equal to 22 0/7 weeks and less than or equal to 36 6/7 weeks
- Subject has documented intact amniotic membranes
- Subject's care provider plans to or has performed an amniocentesis procedure
- Subject has had evidence of spontaneous preterm labor as evidenced by documented regular uterine contractions (greater than or equal to four per hour, or if less than 26 weeks gestation, cramping or backache) and one or more of the following:
Show all 10Show fewer
- Progressive cervical change with cervical dilation of greater than or equal to 2 cm
- Effacement of greater than or equal to 50%
- Cervical length of less than or equal to 30 mm via transvaginal ultrasound
- Positive fetal fibronectin test
Who cannot join
- Subject has documented ruptured amniotic membranes
- Subject has fetus with major fetal anomaly or chromosomal aneuploidy
- Subject has medical indication for preterm birth (e.g. pre-eclampsia)
- Subject is unable to provide written informed consent
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites, 19 recruiting
- Recruiting
Cooper University Hospital
Camden, New Jersey, 08103
Clare Hansen, 856-968-7547, hansen-clare@cooperhealth.edu
Thomas Westover, MD
- Recruiting
Carolinas Medical Center /Dept. OB/GYN
Charlotte, North Carolina, 28203
Nicki Dimaria, RN, 704-355-8834, nicki.dimaria@carolinashealthcare.org
Albert Franco, MD
- Recruiting
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Peggy Walsh, 513-862-2707, peggy_walsh@trihealth.com
Kim Brady, MD
- Recruiting
Greater Cincinnati Medical Center
Cincinnati, Ohio, 45267
Chris DeAmond, 513-584-4130, christine.deamond@uc.edu
David Lewis, MD
- Recruiting
Presbyterian St. Luke's Medical Center
Denver, Colorado, 80218
Jeri Lech, BSN, 303-523-0719, jeri_lech@pediatrix.com
Julie Rael, BSN
- Withdrawn
Swedish Medical Center
Englewood, Colorado, 80110
- Recruiting
UMCG Dept of OB/GYN
Greenville, South Carolina, 29605
Chrystal Prater, RN, 864-455-4872, cprater@ghs.org
Kenneth Trofatter, MD
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Cathy McCormick, RN, 317-630-6572, catmccor@iupui.edu
David Haas, MD
- Recruiting
Long Beach Memorial Hospital
Long Beach, California, 90801
Christine Preslicka, BSN, 562-933-2755, cpreslicka@memorialcare.org
BSN
- Recruiting
Norton Downtown
Louisville, Kentucky, 40202
Chrisitina Motsinger, 502-629-2433, christina.motsinger@nortonhealthcare.org
Helen How, MD
- Recruiting
Banner Desert Memorial Medical Center
Mesa, Arizona, 85202
Melissa Ingersoll, RN, 602-239-3632, melissa_ingersoll@pediatrix.com
Amanda Osbourne, BSN
- Recruiting
Mount Sinai School of Medicine
New York, New York, 10029
Nokmenee Chhun, 212-241-6551, nok.chhun@mssm.edu
Keith Eddleman, MD
- Recruiting
Thomas Jefferson University Medical Center
Philadelphia, Pennsylvania, 19107
Susan Weiner, MSN, 215-955-9243, susan.weiner@jefferson.edu
Jason Baxter, MD
- Recruiting
Banner Good Samaritan Hospital
Phoenix, Arizona, 85006
Melissa Ingersoll, BSN, 602-239-3632, melissa_ingersoll@pediatrix.com
Amanda Osbourne, BSN
- Recruiting
University of Pittsburgh, Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Margaret Cotroneo, BSN, 412-641-4055
Terri Kamon, BSN
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Monica Rincon, BSN, 503-494-8748, rincon@ohsu.edu
BS
- Recruiting
Good Samaritan Hospital
San Jose, California, 95008
Kimberly Mallory, BSN, 408-761-3565, kimberly_mallory@pediatrix.com
Tammy Meyer, BSN
- Recruiting
Swedish Medical Center
Seattle, Washington, 98122
Theresa Murray, BSN, 206-215-3541, theresa_murray@pediatrix.com
David Luthy, MD
- Withdrawn
University of Washington Medical Center
Seattle, Washington, 98195
- Recruiting
St. Louis University School of Medicine
St Louis, Missouri, 63117
Brittaney Whisenand, RN, 314-977-2161, bwhisena@slu.edu
Margot Hirling, 314-977-7482, mhirling@slu.edu
- Recruiting
Tucson Medical Center
Tucson, Arizona, 85712
Diane Mercer, BSN, 520-881-9662, mercer.diane@gmail.com
Hugh Miller, MD
About this study
Official title: Development of a Non-invasive Test to Detect Intra-amniotic Infection and Predict Preterm Birth in Women Presenting With Preterm Labor and and Intact Amniotic Membranes
The purpose of this study is to collect clinical specimens and corresponding clinical data to develop a non-invasive test for detection of intra-amniotic infection and prediction of preterm birth in women and intact amniotic membranes. The specimens collected will be used to develop a specific biomarker panel and algorithm using immunoassays for optimal detection of intra-amniotic infection in women with preterm labor and intact amniotic membranes.
Read the detailed description
Intra-amniotic infection (IAI) is an acute bacterial infection of the amniotic fluid and intrauterine contents during pregnancy and occurs in 4% to 10% of all deliveries (Newton, ER., 1993. Newton, ER, et al., 1989. Soper, DE, et al., 1989). IAI is an important cause of maternal and neonatal morbidity. Identifying and appropriately treating women with IAI is, therefore, a major obstetrical challenge.
Intrauterine infection may occur early in pregnancy and remain undetected for a prolonged period, thus exposing the fetus to the effects of infection/inflammation for a considerable period. Ideally, an early diagnosis of IAI is important to allow timely treatment and intervention. Unfortunately, the early diagnosis is difficult because the clinical signs and symptoms of IAI may occur late in the course of the infection and are neither sensitive nor specific. Therefore, to avoid a delay in diagnosis a high degree of suspicion and the appropriate use of adjunctive laboratory tests are warranted.
- Conditions
- Intra-amniotic Infection
- Keywords
- Preterm Labor, Preterm Birth, Intra-amniotic Infection, Pregnancy, Women
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
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 in preterm labor with intact amniotic membranes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of immunoassay panel to detect intra-amniotic infection in target population.
Measured: Presentation to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProteoGenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Obstetrix Medical Group
- Investigators
- Andrew Combs, MD, PhD, Principal investigator, Obstetrix Medical Group of California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700219
- Sponsor's protocol ID
- PGX01-OBX0006
- Acronym
- IAI
- Status last verified
- Jul 2010
- First submitted
- 13 Jun 2008
- Last updated
- 21 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Combs CA, Garite TJ, Lapidus JA, Lapointe JP, Gravett M, Rael J, Amon E, Baxter JK, Brady K, Clewell W, Eddleman KA, Fortunato S, Franco A, Haas DM, Heyborne K, Hickok DE, How HY, Luthy D, Miller H, Nageotte M, Pereira L, Porreco R, Robilio PA, Simhan H, Sullivan SA, Trofatter K, Westover T; Obstetrix Collaborative Research Network. Detection of microbial invasion of the amniotic cavity by analysis of cervicovaginal proteins in women with preterm labor and intact membranes. Am J Obstet Gynecol. 2015 Apr;212(4):482.e1-482.e12. doi: 10.1016/j.ajog.2015.02.007. Epub 2015 Feb 14.
PubMed 25687566
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
- Development of a Non-invasive Test to Detect Intra-amniotic Infection and Predict Preterm Birth in Women Presenting With Preterm Labor and and Intact Amniotic Membranes
- ClinicalTrials.gov ID
- NCT00700219
- Acronym / sponsor ID
- IAI / PGX01-OBX0006
- Conditions
- Intra-amniotic Infection
- Keywords
- Preterm Labor, Preterm Birth, Intra-amniotic Infection, Pregnancy, Women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- ProteoGenix, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Obstetrix Medical Group
- Study start
- Jun 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 18 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 collect clinical specimens and corresponding clinical data to develop a non-invasive test for detection of intra-amniotic infection and prediction of preterm birth in women and intact amniotic membranes. The specimens collected will be used to develop a specific biomarker panel and algorithm using immunoassays for optimal detection of intra-amniotic infection in women with preterm labor and intact amniotic membranes.
Detailed description
Intra-amniotic infection (IAI) is an acute bacterial infection of the amniotic fluid and intrauterine contents during pregnancy and occurs in 4% to 10% of all deliveries (Newton, ER., 1993. Newton, ER, et al., 1989. Soper, DE, et al., 1989). IAI is an important cause of maternal and neonatal morbidity. Identifying and appropriately treating women with IAI is, therefore, a major obstetrical challenge.
Intrauterine infection may occur early in pregnancy and remain undetected for a prolonged period, thus exposing the fetus to the effects of infection/inflammation for a considerable period. Ideally, an early diagnosis of IAI is important to allow timely treatment and intervention. Unfortunately, the early diagnosis is difficult because the clinical signs and symptoms of IAI may occur late in the course of the infection and are neither sensitive nor specific. Therefore, to avoid a delay in diagnosis a high degree of suspicion and the appropriate use of adjunctive laboratory tests are warranted.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Women presenting in preterm labor with intact amniotic membranes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women presenting to labor and delivery with signs and symptoms of preterm labor and documented intact amntiotic membranes
Key inclusion criteria (10 listed)
- Subject is greater than or equal to 18 years of age
- Subject has singleton gestation
- Subject has fetus with gestational age greater than or equal to 22 0/7 weeks and less than or equal to 36 6/7 weeks
- Subject has documented intact amniotic membranes
- Subject's care provider plans to or has performed an amniocentesis procedure
Key exclusion criteria (4 listed)
- Subject has documented ruptured amniotic membranes
- Subject has fetus with major fetal anomaly or chromosomal aneuploidy
- Subject has medical indication for preterm birth (e.g. pre-eclampsia)
- Subject is unable to provide written 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
Performance of immunoassay panel to detect intra-amniotic infection in target population.
Time frame: Presentation to delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2010.
- Derived from this study: PubMed 25687566Combs CA, Garite TJ, Lapidus JA, Lapointe JP, Gravett M, Rael J, Amon E, Baxter JK, Brady K, Clewell W, Eddleman KA, Fortunato S, Franco A, Haas DM, Heyborne K, Hickok DE, How HY, Luthy D, Miller H, Nageotte M, Pereira L, Porreco R, Robilio PA, Simhan H, Sullivan SA, Trofatter K, Westover T; Obstetrix Collaborative Research Network. Detection of microbial invasion of the amniotic cavity by analysis of cervicovaginal proteins in women with preterm labor and intact membranes. Am J Obstet Gynecol. 2015 Apr;212(4):482.e1-482.e12. doi: 10.1016/j.ajog.2015.02.007. Epub 2015 Feb 14.
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.
Andrew Combs, MD, PhD principal investigator
Obstetrix Medical Group of California
21 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, run by ProteoGenix, Inc. at 21 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 10 inclusion and 4 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 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 21 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Desiree Hollemon, MSN, MPH (503-748-4067, hollemon@proteogenix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of immunoassay panel to detect intra-amniotic infection in target population. (time frame: Presentation to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00700219, which also lists 1 linked publication.
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.