Preterm BirthNCT03443154
VF Test for Prediction of Extremely PTB After Cerclage
An observational study of Preterm Birth and Infection, run by Pediatrix.
Trial summary
The purpose of this research study is to determine if a vaginal fluid (VF) test can predict very early preterm birth in patients who are scheduled to have an exam indicated cerclage for severe cervical shortening. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth, Infection
- What is being tested?
- VF-Test
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to 1 Jun 2018
- 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: Hospital based patients
Who may be able to join
- Participant age 18 years or older
- Gestational age between 16w0d to 25w6d
- Singleton fetus with no apparent major anomalies on ultrasound exam
- Sonographically absent cervical length and/or sterile digital exam of 2cm or greater dilation
- Exam-indicated cervical cerclage has been recommended by clinician and patient agrees to proceed with cervical cerclage placement
- Decision has been made by provider to perform pre-cerclage amniocentesis to rule-out infection, with the understanding that cerclage is contraindicated if findings indicate probable or definitive infection, and patient agrees.
Who cannot join
- Planned termination of pregnancy
- Clinical features consistent with placental abruption or chorioamnionitis
- Need for immediate delivery based on maternal or fetal issues
- Fetus with ultrasound-determined major congenital anomalies
- Multiple gestation
- Rupture of membranes
- Patient does not give consent to participate in this study
About this study
Official title: Vaginal Fluid (VF) Test VF-Test™ for Prediction of Extremely Preterm Birth After Exam-Indicated Cerclage Protocol for Prospective, Multicenter, Cohort Clinical Trial
The purpose of this research study is to determine if a vaginal fluid (VF) test can predict very early preterm birth in patients who are scheduled to have an exam indicated cerclage for severe cervical shortening.
Prior to participants undergoing a scheduled amniocentesis two swabs to collect vaginal secretions for the VF tests will be done. During the amniocentesis your doctor will remove amniotic fluid as part of the routine clinical care. From that fluid sample, the study will use less than a quarter teaspoon for the amniotic fluid study test (AF test). Data regarding maternal and birth outcomes will be collected by medical record review.
Read the detailed description
The purpose of this research study is to determine if a vaginal fluid (VF) test can predict very early preterm birth in patients who are scheduled to have an exam indicated cerclage for severe cervical shortening.
Prior to participants undergoing a scheduled amniocentesis, an ultrasound will be done to confirm cervical length and dilation. During a separate sterile speculum exam, the physician will use two swabs to collect vaginal secretions for the VF test. During the amniocentesis the doctor will remove approximately 2 teaspoon of amniotic fluid as part of your standard clinical care. From that fluid sample, the study will use less than a quarter teaspoon for a amniotic fluid study test (AF test). Data regarding maternal and birth outcomes will be collected by medical record review.
The vaginal fluid (VF) sample collection will take approximately 15 minutes to do. The total time in the study is about seven and a half months (from the time the patient consents until 4 weeks after delivery). The only study procedure the patient will experience during her study participation is the collection of the vaginal fluid specimens.
- Conditions
- Preterm Birth, Infection
- Being tested
- VF-Test
- Keywords
- Cerclage, Preterm birth
- Medical subject headings
- Premature Birth, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VF-TestDiagnostic test
Also called vaginal fluid test.
A vaginal fluid test of interleukin-6 (IL-6) and alphafetoprotein (AFP).
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of very preterm birth (PTB)
Rate of Very PTB (PTB at less than 28 weeks of pregnancy)
Measured: Time frame measured on the date of infant was born. We anticipate this time frame to be approximately 20 weeks.
Secondary outcomes (4)
Rate of Delivery within 7 days of cervical cerclage
Rate of Delivery within 7 days of cervical cerclage placement
Measured: Time frame measured from the date the cerclage was placed until 7 days later
Rate of Delivery at later than 34 weeks of pregnancy
Rate of Delivery at later than 34 weeks of pregnancy (ie. 34 week pregnant until 42 weeks)
Measured: Time frame measured from the time the patient reaches 34 weeks 1 day of pregnancy until birth
Rate of a positive VF test results in association with adverse maternal and perinatal outcomes.
Rate of a positive VF test results in association with adverse maternal and perinatal outcomes. (defined as death or one or more pre-specified morbidities)
Measured: Time frame measured from the time of VF test until 28 days after delivery.
Comparison of AF Test and VF Test results in prediction of a positive amniotic fluid culture
Comparison of amniotic fluid (AF) Test and vaginal fluid (VF) Test results in prediction of a positive amniotic fluid culture
Measured: Time frame measured at the time of the amniocentesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study startJun 2018 (estimated)
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Why it stopped: Industry sponsor withdrew financial support as well as the testing equipment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Collaborators
- Hologic, Inc.
- Responsible party
- Sponsor
- Investigators
- Jeroen Vanderhoeven, MD, Principal investigator, Pediatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443154
- Sponsor's protocol ID
- OBX0039
- Status last verified
- Feb 2018
- First submitted
- 16 Feb 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided at this time
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Fluid (VF) Test VF-Test™ for Prediction of Extremely Preterm Birth After Exam-Indicated Cerclage Protocol for Prospective, Multicenter, Cohort Clinical Trial
- ClinicalTrials.gov ID
- NCT03443154
- Acronym / sponsor ID
- OBX0039
- Conditions
- Preterm Birth, Infection
- Keywords
- Cerclage, Preterm birth
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Industry sponsor withdrew financial support as well as the testing equipment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Collaborators
- Hologic, Inc.
- Study start
- Jun 2018 (estimated)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 22 Feb 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.
The purpose of this research study is to determine if a vaginal fluid (VF) test can predict very early preterm birth in patients who are scheduled to have an exam indicated cerclage for severe cervical shortening.
Prior to participants undergoing a scheduled amniocentesis two swabs to collect vaginal secretions for the VF tests will be done. During the amniocentesis your doctor will remove amniotic fluid as part of the routine clinical care. From that fluid sample, the study will use less than a quarter teaspoon for the amniotic fluid study test (AF test). Data regarding maternal and birth outcomes will be collected by medical record review.
Detailed description
The purpose of this research study is to determine if a vaginal fluid (VF) test can predict very early preterm birth in patients who are scheduled to have an exam indicated cerclage for severe cervical shortening.
Prior to participants undergoing a scheduled amniocentesis, an ultrasound will be done to confirm cervical length and dilation. During a separate sterile speculum exam, the physician will use two swabs to collect vaginal secretions for the VF test. During the amniocentesis the doctor will remove approximately 2 teaspoon of amniotic fluid as part of your standard clinical care. From that fluid sample, the study will use less than a quarter teaspoon for a amniotic fluid study test (AF test). Data regarding maternal and birth outcomes will be collected by medical record review.
The vaginal fluid (VF) sample collection will take approximately 15 minutes to do. The total time in the study is about seven and a half months (from the time the patient consents until 4 weeks after delivery). The only study procedure the patient will experience during her study participation is the collection of the vaginal fluid specimens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital based patients
Key inclusion criteria (6 listed)
- Participant age 18 years or older
- Gestational age between 16w0d to 25w6d
- Singleton fetus with no apparent major anomalies on ultrasound exam
- Sonographically absent cervical length and/or sterile digital exam of 2cm or greater dilation
- Exam-indicated cervical cerclage has been recommended by clinician and patient agrees to proceed with cervical cerclage placement
Key exclusion criteria (7 listed)
- Planned termination of pregnancy
- Clinical features consistent with placental abruption or chorioamnionitis
- Need for immediate delivery based on maternal or fetal issues
- Fetus with ultrasound-determined major congenital anomalies
- Multiple gestation
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 |
|---|---|---|
| VF-TestAlso: vaginal fluid test.A vaginal fluid test of interleukin-6 (IL-6) and alphafetoprotein (AFP). | Diagnostic test | – |
Primary outcome
Rate of very preterm birth (PTB)
Time frame: Time frame measured on the date of infant was born. We anticipate this time frame to be approximately 20 weeks.
Rate of Very PTB (PTB at less than 28 weeks of pregnancy)
4 secondary outcomes
Rate of Delivery within 7 days of cervical cerclage
Time frame: Time frame measured from the date the cerclage was placed until 7 days later
Rate of Delivery at later than 34 weeks of pregnancy
Time frame: Time frame measured from the time the patient reaches 34 weeks 1 day of pregnancy until birth
Rate of a positive VF test results in association with adverse maternal and perinatal outcomes.
Time frame: Time frame measured from the time of VF test until 28 days after delivery.
Comparison of AF Test and VF Test results in prediction of a positive amniotic fluid culture
Time frame: Time frame measured at the time of the amniocentesis
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 27 Jun 2018.
- Individual participant dataSharing planned: Undecided. Not decided at this time
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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.
Jeroen Vanderhoeven, MD principal investigator
Pediatrix
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Infection, run by Pediatrix.
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 7 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Rate of very preterm birth (PTB) (time frame: Time frame measured on the date of infant was born. We anticipate this time frame to be approximately 20 weeks.). 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 27 Jun 2018.