VF Test for Prediction of Extremely PTB After Cerclage

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.

Study Overview

• Status: Withdrawn
• Conditions: Preterm Birth; Infection
• Intervention / Treatment: 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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Hospital based patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of very preterm birth (PTB)	Rate of Very PTB (PTB at less than 28 weeks of pregnancy)	Time frame measured on the date of infant was born. We anticipate this time frame to be approximately 20 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Delivery within 7 days of cervical cerclage	Rate of Delivery within 7 days of cervical cerclage placement	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)	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)	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	Time frame measured at the time of the amniocentesis

Collaborators and Investigators

• Sponsor: Pediatrix
• Collaborators: Hologic, Inc.
• Investigators: Principal Investigator: Jeroen Vanderhoeven, MD, Pediatrix

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Preterm birth; Cerclage
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: OBX0039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not decided at this time

Drug and device information, study documents

• 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