Pre-term BirthNCT01955148
fFN Clinical Evaluation in Asymptomatic Women at High Risk for Preterm Birth
An observational study of Pre-term Birth, run by Hologic, Inc. at 16 sites in United States.
Trial summary
This study is designed to determine if quantitative analysis of fetal Fibronectin (fFN) can be used to advance prediction of spontaneous preterm birth (sPTB). This will be a prospective observational multi-center study with approximately 15 to 20 US sites, and approximately 1210 subjects evaluating the clinical… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-term Birth
- How many people
- 1,210 participants
- Where
- 16 sitesUnited States
- Study dates
- Oct 2013to Sep 2016
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Only subjects who are at high risk for preterm birth and meet the inclusion criteria will be included in this study. Subjects may be recruited from each clinical site's routine or referral population. Pregnant women who meet the study eligibility criteria will be screened for possible inclusion in the study.
Who may be able to join
- Pregnant women from 16 weeks, 0 days to 21 weeks, 6 days' gestation
- Maternal age ≥18 years of age
- Subject has signed and dated an Institutional Review Board (IRB) approved consent form to participate in the study
- Subjects for this study must be at high risk for preterm birth as indicated by at least one of the following:
- A previous delivery of a live born singleton between 20 weeks, 0 days and 36 weeks, 6 days due to spontaneous preterm premature labor or preterm rupture of fetal membranes
- Short cervical length (≤25 mm) determined by transvaginal ultrasound
Show all 10Show fewer
- Current twin pregnancy
- Cervical cerclage in a prior pregnancy
- Prior cone biopsy
- Prior LEEP / LLETZ
Who cannot join
- Maternal age under 18
- Suspected or proven rupture of fetal membranes at the time of specimen collection
- Known significant congenital structural or chromosomal fetal anomaly
- Women with moderate or gross bleeding evident on speculum examination
- Women who have had sexual intercourse within 24 hours prior to specimen collection
- Cervical cerclage at time of specimen collection
- Current triplet (or more) pregnancy
- Placenta previa with active bleeding
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites, 15 recruiting
- Recruiting
Perinatal Associates of New Mexico
Albuquerque, New Mexico, 87106
Michael S Ruma, MD, BS, MPH, 505-764-9535, michael.ruma@gmail.com
Michael S Ruma,, BS, MPH
- Recruiting
University of Alabama
Birmingham, Alabama, 35233
Pam Files, RN, pfiles@uabmc.edu
Rachel LeDuke, RN, rleduke@uabmc.edu
- Not yet recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Errol Norwitz, M.D., Ph.D., 617-636-2382, enorwitz@tuftsmedicalcenter.org
Errol Norwitz, MD, Ph.D.
- Recruiting
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Zoe Frolking, zoe_frolking@med.unc.edu
Karen Dorman, RN, 919-966-2550, kdorman@med.unc.edu
- Active, not recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
Regional Obstetrical Consultants
Chattanooga, Tennessee, 37403-2724
Lorrie Mason, NP, 423-826-8086 ext. 423, lorrie@rocob.com
David Adair, MD
- Recruiting
Ohio State University Medical Center
Columbus, Ohio, 43210
Hetty Walker, RNC-OB, 614-293-8949, hetty.walker@osumc.edu
Catalin Buhimschi, MD
- Recruiting
University of Texas - Medical Branch at Galveston
Galveston, Texas, 77555
Ashley Salazar, RN, MSN, 409-772-0312, assalaza@utmb.edu
George Saade, MD
- Recruiting
University of Texas-Houston
Houston, Texas, 77030
Maria Hutchinson, Maria.S.Keefer@uth.tmc.edu
Sean Blackwell, MD
- Recruiting
Lawrence OB/GYN Associates
Lawrenceville, New Jersey, 08648
Melissa Witt, 609-803-2378, mwitt@lawrenceobgyn.com
Kira Pryzbylko, MD
- Recruiting
Christiana Hospital
Newark, Delaware, 19713
Stephanie Lynch, RN, BSN, 302-733-3576, SLynch@Christianacare.org
Anthony Sciscione, DO
- Recruiting
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Christy Zornes, 405-271-8001 ext. 48137, Christy-Zornes@ouhsc.edu
Eric Knudtson, MD
- Recruiting
University of Pittsburgh - Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
Meliss Bickus, RN, 412-641-4874, Bickmt2@mail.magee.edu
Hyagriv Simhan, MD
- Recruiting
Jean Brown Research
Salt Lake City, Utah, 84124
Allison Jones, 801-261-2000, ajones@jeanbrownresearch.com
Allen Rappleye, MD
- Recruiting
Women's Health Care Research Corp.
San Diego, California, 92123
Angelica Castillo, 858-505-8672, angelica@womenwellness.net
Rovena Reagan, MD
- Recruiting
Baystate Medical Center
Springfield, Massachusetts, 01199
Joanne Montgomery, 413-794-3118, Joanne.montgomery@baystatehealth.org
Glenn Markenson, MD
About this study
Official title: Prospective Phase III Evaluation Of Fetal Fibronectin In A High Risk Asymptomatic Population For The Prediction Of Spontaneous Preterm Birth
This study is designed to determine if quantitative analysis of fetal Fibronectin (fFN) can be used to advance prediction of spontaneous preterm birth (sPTB). This will be a prospective observational multi-center study with approximately 15 to 20 US sites, and approximately 1210 subjects evaluating the clinical utility of the Rapid fFN 10Q system for preterm birth risk assessment. A single fFN specimen will be collected from each subject between 16 weeks, 0 days and 21 weeks, 6 days. The primary and secondary maternal outcome measures will be determined based on the date of delivery and the estimated date of confinement (EDC), which will be evaluated in a standardized manner.
Read the detailed description
Hologic has developed a quantitative test to assess the amount of fetal fibronectin (fFN) present in cervicovaginal secretions, and evaluate the clinical utility of the test in assessing spontaneous Pre-Term Bith risk in a high risk population. Identifying women at high risk of giving birth prematurely can be challenging. It is believed that higher levels of fFn measured in vaginal fluid suggest a woman is at a greater risk for delivering early. fFN testing is already approved for use in women from weeks 22 to 35 of pregnancy. The goal of this study is to evaluate the benefits of collecting fFN measurements from a vaginal fluid specimen taken during early pregnancy (from 16 weeks to 22 weeks) to assess the risk of pre-term birth.
- Conditions
- Pre-term Birth
- Keywords
- PTB, sPTB, cervical cerclage, LEEP, PROM, short cervix
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 |
|---|---|---|
| Prior sPTB or PROM | Women who have had a previous delivery of a live born singleton between 20 weeks, 0 days and 36 weeks, 6 days due to spontaneous preterm premature labor or preterm rupture of fetal membranes | |
| Short cervical length | Short cervical length (≤25 mm) determined by transvaginal ultrasound | |
| Twin Pregnancy | Current twin pregnancy | |
| Prior cervicdal surgeries | Cervical cerclage in a prior pregnancy or prior cone biopsy or prior LEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with a high and low level of fFN as a Measure of Predicting Pre-Term Birth
To determine whether the rate of spontaneous delivery < 35 weeks in women with a high level of fFN (equivalent to ≥ 200 ng/mL) is greater than in women with a low fFN (< 10 ng/mL) measured from 16 weeks, 0 days to 21 weeks, 6 days' gestation in a high risk coho
Measured: 18 months
Secondary outcomes (1)
Number of Participants with a moderate level of fFN as a Measure of Predicting Pre-Term Birth
To determine whether the rate of spontaneous delivery < 35 weeks in women with a moderate level of fFN (10-199 ng/mL) is greater than in women with a low fFN (< 10 ng/mL) measured from 16 weeks, 0 days to 21 weeks, 6 days' gestation in a high risk cohort.
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 posted7 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-term BirthStudies 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
- 1,210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean C Blackwell, MD, Principal investigator, UTHealth - Medical School at HoustonErrol Norwitz, MD, Ph.D., Principal investigator, Tufts Medical CenterJoseph Biggio, MD, Principal investigator, University of Alabama at BirminghamDavid Adair, MD, Principal investigator, Regional Obstetrics Consultants, PCAnthony Sciscione, MD, Principal investigator, Christiana Care Health Services, Inc.Eugene Chang, MD, Principal investigator, Medical University of South CarolinaEric Knudtson, MD, Principal investigator, Board of Regents of the University of OklahomaKathryn Menard, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955148
- Sponsor's protocol ID
- 10Q01
- Status last verified
- Aug 2015
- First submitted
- 24 Sep 2013
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase III Evaluation Of Fetal Fibronectin In A High Risk Asymptomatic Population For The Prediction Of Spontaneous Preterm Birth
- ClinicalTrials.gov ID
- NCT01955148
- Acronym / sponsor ID
- 10Q01
- Conditions
- Pre-term Birth
- Keywords
- PTB, sPTB, cervical cerclage, LEEP, PROM, short cervix
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,210 participants (estimated)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 7 Oct 2013 (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.
This study is designed to determine if quantitative analysis of fetal Fibronectin (fFN) can be used to advance prediction of spontaneous preterm birth (sPTB). This will be a prospective observational multi-center study with approximately 15 to 20 US sites, and approximately 1210 subjects evaluating the clinical utility of the Rapid fFN 10Q system for preterm birth risk assessment. A single fFN specimen will be collected from each subject between 16 weeks, 0 days and 21 weeks, 6 days. The primary and secondary maternal outcome measures will be determined based on the date of delivery and the estimated date of confinement (EDC), which will be evaluated in a standardized manner.
Detailed description
Hologic has developed a quantitative test to assess the amount of fetal fibronectin (fFN) present in cervicovaginal secretions, and evaluate the clinical utility of the test in assessing spontaneous Pre-Term Bith risk in a high risk population. Identifying women at high risk of giving birth prematurely can be challenging. It is believed that higher levels of fFn measured in vaginal fluid suggest a woman is at a greater risk for delivering early. fFN testing is already approved for use in women from weeks 22 to 35 of pregnancy. The goal of this study is to evaluate the benefits of collecting fFN measurements from a vaginal fluid specimen taken during early pregnancy (from 16 weeks to 22 weeks) to assess the risk of pre-term birth.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prior sPTB or PROM | – | –Women who have had a previous delivery of a live born singleton between 20 weeks, 0 days and 36 weeks, 6 days due to spontaneous preterm premature labor or preterm rupture of fetal membranes |
| Short cervical length | – | –Short cervical length (≤25 mm) determined by transvaginal ultrasound |
| Twin Pregnancy | – | –Current twin pregnancy |
| Prior cervicdal surgeries | – | –Cervical cerclage in a prior pregnancy or prior cone biopsy or prior LEEP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Only subjects who are at high risk for preterm birth and meet the inclusion criteria will be included in this study. Subjects may be recruited from each clinical site's routine or referral population. Pregnant women who meet the study eligibility criteria will be screened for possible inclusion in the study.
Key inclusion criteria (10 listed)
- Pregnant women from 16 weeks, 0 days to 21 weeks, 6 days' gestation
- Maternal age ≥18 years of age
- Subject has signed and dated an Institutional Review Board (IRB) approved consent form to participate in the study
- Subjects for this study must be at high risk for preterm birth as indicated by at least one of the following:
Key exclusion criteria (8 listed)
- Maternal age under 18
- Suspected or proven rupture of fetal membranes at the time of specimen collection
- Known significant congenital structural or chromosomal fetal anomaly
- Women with moderate or gross bleeding evident on speculum examination
- Women who have had sexual intercourse within 24 hours prior to specimen collection
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
Number of Participants with a high and low level of fFN as a Measure of Predicting Pre-Term Birth
Time frame: 18 months
To determine whether the rate of spontaneous delivery < 35 weeks in women with a high level of fFN (equivalent to ≥ 200 ng/mL) is greater than in women with a low fFN (< 10 ng/mL) measured from 16 weeks, 0 days to 21 weeks, 6 days' gestation in a high risk coho
1 secondary outcome
Number of Participants with a moderate level of fFN as a Measure of Predicting Pre-Term Birth
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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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.
Sean C Blackwell, MD principal investigator
UTHealth - Medical School at Houston
Errol Norwitz, MD, Ph.D. principal investigator
Tufts Medical Center
Joseph Biggio, MD principal investigator
University of Alabama at Birmingham
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-term Birth, run by Hologic, Inc. at 16 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 8 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 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 Christina M Mastandrea (5082638772, christina.mastandrea@hologic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with a high and low level of fFN as a Measure of Predicting Pre-Term Birth (time frame: 18 months). 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 26 Aug 2015.