Preterm DeliverySpecOpNCT00883324
Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum
An observational study of Preterm Delivery, run by Hologic, Inc. at 5 sites in United States.
Trial summary
Observational study to determine whether the proposed method of fFN specimen collection without a speculum is substantially equivalent to the approved method with a speculum examination when obtained at the gestational age of ≥ 24 weeks and ≤ 34, 6 days in symptomatic women and at the gestational age of ≥ 22 weeks, 0… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Delivery
- How many people
- 329 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2009to not given
- 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: Labor and delivery triage, prenatal clinic
Who may be able to join
- Maternal age > 18 years.
- Subject has signed and dated an Institutional Review Board (IRB) or Research Ethics Board (REB) approved consent form to participate in the study.
- Specimen Collection Kit and the Rapid fFN for the TLiIQ® System are currently utilized as standard of care (SOC).
- Gestational age of ≥ 24 weeks, 0 days and ≤ 34 weeks, 6 days for symptomatic subjects. (As defined by ACOG.)
- Gestational age of ≥ 22 weeks, 0 days and ≤ 30 weeks, 6 days for asymptomatic subjects with singleton pregnancies. (As defined by ACOG.)
- Intact amniotic membranes.
Who cannot join
- Placenta previa or abruptio placenta.
- Cervical cerclage.
- Digital examination, vaginal intercourse, or transvaginal ultrasound within 24 hours prior to the fFN sample collection.
- Moderate or gross vaginal bleeding at the time of fFN sample collection. Cervical dilatation ≥ 3 centimeters.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northside Hospital
Atlanta, Georgia, 30342
Presbyterian Hospital
Charlotte, North Carolina, 28204
Kettering Health Network of Kettering Medical Center
Kettering, Ohio, 45429
Yale University Medical Center
New Haven, Connecticut, 06511
Santa Clara Valley Medical Health & Hospital System
San Jose, California, 95128
About this study
Official title: A Phase IIIB Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum
Observational study to determine whether the proposed method of fFN specimen collection without a speculum is substantially equivalent to the approved method with a speculum examination when obtained at the gestational age of ≥ 24 weeks and ≤ 34, 6 days in symptomatic women and at the gestational age of ≥ 22 weeks, 0 days and ≤ 30, 6 days in asymptomatic women. A finding of substantial equivalency would support a modification to the labeling to allow the collection of specimens for fFN determination with or without a speculum examination.
Read the detailed description
The study population will include pregnant women who may be at risk for preterm delivery and require the fFN test, as determined by their doctor to aid in patient management. The subjects may or may not present with symptoms related to preterm labor and must satisfy the device's approved labeling and the eligibility criteria.
For pregnant women with signs of labor, the Fetal Fibronectin (fFN) test is approved for use as an aid to assess the risk of preterm delivery in ≤ 7 or ≤ 14 days from cervicovaginal sample collection that have intact amniotic membranes and minimal cervical dilation (< 3 cm) and are sampled between 24 weeks, 0 days and 34 weeks, 6 days. It is also approved for use with additional clinical information in asymptomatic women with singleton pregnancies when a sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation.
The fFN test is run on The Rapid fFN for the TLiIQ® System and a positive fFN result occurs with concentrations ≥50ng/mL and a negative fFN test with concentrations <50ng/mL.
The current FDA-approved labeling for the collection of the fFN specimen requires a speculum examination; however, the collection of the fFN specimen is often needed when the women first arrives at the hospital labor and delivery unit, where nurses often are not trained or credentialed to perform speculum examinations and a physician may not be readily available to perform the collection. Therefore, there is an unmet need for a simpler collection method.
The test article in this study is the collection of cervicovaginal samples for fFN determination using a standardized collection method without a speculum. The control article in this study is the collection of a cervicovaginal sample for fFN determination using the approved collection method requiring a speculum examination. Both the test and control fFN specimen samples will be collected and evaluated using the approved Rapid fFN for the TLiIQ® System.
The primary objective of this study is to determine whether the proposed method of fFN specimen collection without a speculum is substantially equivalent to the approved method with a speculum examination when obtained at the gestational age of ≥ 24 weeks and ≤ 34, 6 days in symptomatic women and at the gestational age of ≥ 22 weeks, 0 days and ≤ 30, 6 days in asymptomatic women. A finding of substantial equivalency would support a modification to the labeling to allow the collection of specimens for fFN determination with or without a speculum examination.
Hypothesis: The method of fFN specimen collection without a speculum is not inferior to collection with a speculum within a 5% margin of non-inferiority.
- Conditions
- Preterm Delivery
- Keywords
- fFN, fetal fibronectin, non-speculum, risk of preterm delivery
- Medical subject headings
- 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 | fetal fibronectin specimens collected with a speculum | |
| 2 | fetal fibronectin specimens collected without a speculum |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm DeliveryStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 329 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James D. Byrne, M.D., Principal investigator, Santa Clara Valley Medical Health & Hospital SystemMichael Paidas, M.D., Principal investigator, Yale UniversityLarry Matsumoto, M.D., Principal investigator, Northside Hospital Center for Perinatal MedicineJanice Whitty, MD, Principal investigator, Meharry Medical CollegeJohn Allbert, MD, Principal investigator, Presbyterian HospitalAnnette E. Bombrys, DO, Principal investigator, Kettering Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883324
- Sponsor's protocol ID
- D0108001
- Acronym
- SpecOp
- Status last verified
- Jun 2011
- First submitted
- 10 Apr 2009
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum
- ClinicalTrials.gov ID
- NCT00883324
- Acronym / sponsor ID
- SpecOp / D0108001
- Conditions
- Preterm Delivery
- Keywords
- fFN, fetal fibronectin, non-speculum, risk of preterm delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (estimated)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- First posted
- 17 Apr 2009 (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.
Observational study to determine whether the proposed method of fFN specimen collection without a speculum is substantially equivalent to the approved method with a speculum examination when obtained at the gestational age of ≥ 24 weeks and ≤ 34, 6 days in symptomatic women and at the gestational age of ≥ 22 weeks, 0 days and ≤ 30, 6 days in asymptomatic women. A finding of substantial equivalency would support a modification to the labeling to allow the collection of specimens for fFN determination with or without a speculum examination.
Detailed description
The study population will include pregnant women who may be at risk for preterm delivery and require the fFN test, as determined by their doctor to aid in patient management. The subjects may or may not present with symptoms related to preterm labor and must satisfy the device's approved labeling and the eligibility criteria.
For pregnant women with signs of labor, the Fetal Fibronectin (fFN) test is approved for use as an aid to assess the risk of preterm delivery in ≤ 7 or ≤ 14 days from cervicovaginal sample collection that have intact amniotic membranes and minimal cervical dilation (< 3 cm) and are sampled between 24 weeks, 0 days and 34 weeks, 6 days. It is also approved for use with additional clinical information in asymptomatic women with singleton pregnancies when a sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation.
The fFN test is run on The Rapid fFN for the TLiIQ® System and a positive fFN result occurs with concentrations ≥50ng/mL and a negative fFN test with concentrations <50ng/mL.
The current FDA-approved labeling for the collection of the fFN specimen requires a speculum examination; however, the collection of the fFN specimen is often needed when the women first arrives at the hospital labor and delivery unit, where nurses often are not trained or credentialed to perform speculum examinations and a physician may not be readily available to perform the collection. Therefore, there is an unmet need for a simpler collection method.
The test article in this study is the collection of cervicovaginal samples for fFN determination using a standardized collection method without a speculum. The control article in this study is the collection of a cervicovaginal sample for fFN determination using the approved collection method requiring a speculum examination. Both the test and control fFN specimen samples will be collected and evaluated using the approved Rapid fFN for the TLiIQ® System.
The primary objective of this study is to determine whether the proposed method of fFN specimen collection without a speculum is substantially equivalent to the approved method with a speculum examination when obtained at the gestational age of ≥ 24 weeks and ≤ 34, 6 days in symptomatic women and at the gestational age of ≥ 22 weeks, 0 days and ≤ 30, 6 days in asymptomatic women. A finding of substantial equivalency would support a modification to the labeling to allow the collection of specimens for fFN determination with or without a speculum examination.
Hypothesis: The method of fFN specimen collection without a speculum is not inferior to collection with a speculum within a 5% margin of non-inferiority.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –fetal fibronectin specimens collected with a speculum |
| 2 | – | –fetal fibronectin specimens collected without a speculum |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Labor and delivery triage, prenatal clinic
Key inclusion criteria (6 listed)
- Maternal age > 18 years.
- Subject has signed and dated an Institutional Review Board (IRB) or Research Ethics Board (REB) approved consent form to participate in the study.
- Specimen Collection Kit and the Rapid fFN for the TLiIQ® System are currently utilized as standard of care (SOC).
- Gestational age of ≥ 24 weeks, 0 days and ≤ 34 weeks, 6 days for symptomatic subjects. (As defined by ACOG.)
- Gestational age of ≥ 22 weeks, 0 days and ≤ 30 weeks, 6 days for asymptomatic subjects with singleton pregnancies. (As defined by ACOG.)
Key exclusion criteria (4 listed)
- Placenta previa or abruptio placenta.
- Cervical cerclage.
- Digital examination, vaginal intercourse, or transvaginal ultrasound within 24 hours prior to the fFN sample collection.
- Moderate or gross vaginal bleeding at the time of fFN sample collection. Cervical dilatation ≥ 3 centimeters.
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
Not reported in the source record.
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 20 Jun 2011.
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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.
James D. Byrne, M.D. principal investigator
Santa Clara Valley Medical Health & Hospital System
Michael Paidas, M.D. principal investigator
Yale University
Larry Matsumoto, M.D. principal investigator
Northside Hospital Center for Perinatal Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Delivery, 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 6 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: finished, as of the sponsor's last update on 20 Jun 2011. 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 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.
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 20 Jun 2011.