Intra-Amniotic Infection of FoetusNCT03497234
Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test
A study testing Perilynx Analyzer to measure AF and VF fluid in people with Intra-Amniotic Infection of Foetus, run by Hologic, Inc. at 5 sites in United States.
Trial summary
A multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit of collaborating clinical study sites with preterm labor and intact amniotic membranes with and without suspected Intra-Amniotic Infection (IAI). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Intra-Amniotic Infection of Foetus
- What is being tested?
- Perilynx Analyzer to measure AF and VF fluid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Mar 2018to 31 Mar 2020
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subject is ≥ 18 years of age
- Subject has singleton gestation
- Subject has fetus with gestational age ≥ 22 0/7 weeks and ≤ 33 6/7 weeks
- Subject has had evidence of spontaneous preterm labor as evidenced by documented regular uterine contractions (≥4 per hour) and one or more of the following:
- Cervical dilation > 2cm
- Cervical length of ≤25 mm via transvaginal ultrasound
Show all 9Show fewer
- Subject has onset of contractions was within 48 hours of enrollment in the study
- Subject has documented intact amniotic membranes
- Subject's care provider plans to perform an amniocentesis procedure -
Who cannot join
- 1. Subject has documented ruptured amniotic membranes 2. Subject has a fetus with major fetal or genetic anomaly or chromosomal aneuploidy 3. Subject has maternal or fetal indication for preterm birth (e.g., pre-eclampsia) 4. Subject is unable to provide written informed consent 5. Subject has evidence of non-reassuring fetal heart rate tracing requiring immediate delivery 6. Subject has vaginal bleeding within the past 24 hours 7. Subject has advanced labor (cervix >4 cm dilated) 8. Subject has HIV, hepatitis 9. Subject has not been enrolled previously in this study and/or is participating in another study (that in the opinion of the Investigator) may interfere with participation in this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Regional Obstetrical Consultants
Chattanooga, Tennessee, 07102
Ohio State Medical Center
Columbus, Ohio, 43210
Good Samaritan Hospital
Long Beach, California, 95142
Rutgers
Newark, New Jersey, 07102
Willis Knighton
Shreveport, Louisiana, 71118
About this study
Official title: Development of a Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test to Detect Intra-Amniotic Infection and Predict Preterm Birth in Women Presenting With Preterm Labor and Intact Amniotic Membranes
A multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit of collaborating clinical study sites with preterm labor and intact amniotic membranes with and without suspected Intra-Amniotic Infection (IAI).
Read the detailed description
A study on patients in preterm labor for whom the managing physician plans to perform amniocentesis to evaluate for possible infection using conventional, currently available methods. Vaginal fluid will be collected and analyzed and amniotic fluid will also. These tests will be run remotely and not reported to the clinician.
- Conditions
- Intra-Amniotic Infection of Foetus
- Being tested
- Perilynx Analyzer to measure AF and VF fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perilynx Analyzer to measure AF and VF fluidDiagnostic test
Hologic developed a rapid in-vitro diagnostic system composed of an analyzer and cassettes to identify women with intra-amniotic infection.
| Study group | Role | What they receive |
|---|---|---|
| All women eligible to participate | Experimental | All women presenting who sign the consent and found eligible will have a VF and AF sample taken and analyzed on the Perilynx Analyzer to measure AF and VF fluid. This does not affect their regular standard of care and diagnosis Receives: Diagnostic Test: Perilynx Analyzer to measure AF and VF fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance of vaginal fluid test
To assess the performance of a vaginal fluid test for assessing risk of IAI in subjects presenting with preterm labor and intact membranes.
Measured: 18 months
performance of amniocentesis test
To assess the performance of a rapid amniotic fluid test to identify intraamniotic infection (IAI).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start28 Mar 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Why it stopped: Business Strategic Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Amniotic Infection of FoetusStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Mastandrea, Study director, Hologic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497234
- Sponsor's protocol ID
- D0116003
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test to Detect Intra-Amniotic Infection and Predict Preterm Birth in Women Presenting With Preterm Labor and Intact Amniotic Membranes
- ClinicalTrials.gov ID
- NCT03497234
- Acronym / sponsor ID
- D0116003
- Conditions
- Intra-Amniotic Infection of Foetus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Strategic Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 13 Apr 2018 (actual)
- 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.
A multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit of collaborating clinical study sites with preterm labor and intact amniotic membranes with and without suspected Intra-Amniotic Infection (IAI).
Detailed description
A study on patients in preterm labor for whom the managing physician plans to perform amniocentesis to evaluate for possible infection using conventional, currently available methods. Vaginal fluid will be collected and analyzed and amniotic fluid will also. These tests will be run remotely and not reported to the clinician.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit
| Arm | Type | Receives |
|---|---|---|
| All women eligible to participate | Experimental | Diagnostic Test: Perilynx Analyzer to measure AF and VF fluidAll women presenting who sign the consent and found eligible will have a VF and AF sample taken and analyzed on the Perilynx Analyzer to measure AF and VF fluid. This does not affect their regular standard of care and diagnosis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject is ≥ 18 years of age
- Subject has singleton gestation
- Subject has fetus with gestational age ≥ 22 0/7 weeks and ≤ 33 6/7 weeks
- Subject has had evidence of spontaneous preterm labor as evidenced by documented regular uterine contractions (≥4 per hour) and one or more of the following:
- Subject has onset of contractions was within 48 hours of enrollment in the study
Key exclusion criteria (1 listed)
- 1. Subject has documented ruptured amniotic membranes 2. Subject has a fetus with major fetal or genetic anomaly or chromosomal aneuploidy 3. Subject has maternal or fetal indication for preterm birth (e.g., pre-eclampsia) 4. Subject is unable to provide written informed consent 5. Subject has evidence of non-reassuring fetal heart rate tracing requiring immediate delivery 6. Subject has vaginal bleeding within the past 24 hours 7. Subject has advanced labor (cervix >4 cm dilated) 8. Subject has HIV, hepatitis 9. Subject has not been enrolled previously in this study and/or is participating in another study (that in the opinion of the Investigator) may interfere with participation in this study
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 |
|---|---|---|
| Perilynx Analyzer to measure AF and VF fluidHologic developed a rapid in-vitro diagnostic system composed of an analyzer and cassettes to identify women with intra-amniotic infection. | Diagnostic test | All women eligible to participate |
Primary outcome
performance of vaginal fluid test
Time frame: 18 months
To assess the performance of a vaginal fluid test for assessing risk of IAI in subjects presenting with preterm labor and intact membranes.
performance of amniocentesis test
Time frame: 18 months
To assess the performance of a rapid amniotic fluid test to identify intraamniotic infection (IAI).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: No
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.
Christina Mastandrea study director
Hologic, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perilynx Analyzer to measure AF and VF fluid in people with Intra-Amniotic Infection of Foetus, run by Hologic, Inc. at 5 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 9 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: withdrawn, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 was withdrawn before enrolling participants, so there are no results.
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?
performance of vaginal fluid test (time frame: 18 months). The study lists 2 primary outcomes in all. 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 30 Jul 2018.