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VF Test for Prediction of Extremely PTB After Cerclage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03443154
Recruitment Status : Withdrawn (Industry sponsor withdrew financial support as well as the testing equipment.)
First Posted : February 22, 2018
Last Update Posted : June 27, 2018
Sponsor:
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

Brief 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.

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.


Condition or disease Intervention/treatment
Preterm Birth Infection Diagnostic Test: VF-Test

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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : June 2018
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Intervention Details:
  • Diagnostic Test: VF-Test
    A vaginal fluid test of interleukin-6 (IL-6) and alphafetoprotein (AFP).
    Other Name: vaginal fluid test.


Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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 within 7 days of cervical cerclage placement

  2. 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 Delivery at later than 34 weeks of pregnancy (ie. 34 week pregnant until 42 weeks)

  3. 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. ]
    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)

  4. 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 ]
    Comparison of amniotic fluid (AF) Test and vaginal fluid (VF) Test results in prediction of a positive amniotic fluid culture



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital based patients
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443154


Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety
Hologic, Inc.
Investigators
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Principal Investigator: Jeroen Vanderhoeven, MD Mednax Center for Research, Education, Quality and Safety

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Responsible Party: Mednax Center for Research, Education, Quality and Safety
ClinicalTrials.gov Identifier: NCT03443154     History of Changes
Other Study ID Numbers: OBX0039
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not decided at this time

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mednax Center for Research, Education, Quality and Safety:
Cerclage
Preterm birth

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