Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum (SpecOp)

This study has been completed.
Sponsor:
Information provided by:
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT00883324
First received: April 10, 2009
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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.


Condition
Preterm Delivery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Phase IIIB Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum

Further study details as provided by Hologic, Inc.:

Estimated Enrollment: 329
Study Start Date: March 2009
Groups/Cohorts
1
fetal fibronectin specimens collected with a speculum
2
fetal fibronectin specimens collected without a speculum

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Labor and delivery triage, prenatal clinic

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883324

Locations
United States, California
Santa Clara Valley Medical Health & Hospital System
San Jose, California, United States, 95128
United States, Connecticut
Yale University Medical Center
New Haven, Connecticut, United States, 06511
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
United States, North Carolina
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
United States, Ohio
Kettering Health Network of Kettering Medical Center
Kettering, Ohio, United States, 45429
Sponsors and Collaborators
Hologic, Inc.
Investigators
Principal Investigator: James D. Byrne, M.D. Santa Clara Valley Medical Health & Hospital System
Principal Investigator: Michael Paidas, M.D. Yale University
Principal Investigator: Larry Matsumoto, M.D. Northside Hospital Center for Perinatal Medicine
Principal Investigator: Janice Whitty, MD Meharry Medical College
Principal Investigator: John Allbert, MD Presbyterian Hospital
Principal Investigator: Annette E. Bombrys, DO Kettering Health Network
  More Information

No publications provided

Responsible Party: Arthur Friedman, Senior Vice President of Quality, Regulatory and Clinical, Hologic
ClinicalTrials.gov Identifier: NCT00883324     History of Changes
Other Study ID Numbers: D0108001
Study First Received: April 10, 2009
Last Updated: June 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Hologic, Inc.:
fFN
fetal fibronectin
non-speculum
risk of preterm delivery

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on October 20, 2014