Clinical trial NCT03443154: VF Test for Prediction of Extremely PTB After Cerclage
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Preterm Birth
Infection
Keywords: Cerclage
Preterm birth
Lead sponsor: Pediatrix
Sponsor class: OTHER
Collaborators: name: Hologic, Inc.
First posted: 2018-02-22
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital based patients

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.

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.

Eligibility 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

Primary outcomes:
measure: Rate of very preterm birth (PTB)
timeFrame: Time frame measured on the date of infant was born. We anticipate this time frame to be approximately 20 weeks.
Secondary outcomes:
measure: Rate of Delivery within 7 days of cervical cerclage
timeFrame: Time frame measured from the date the cerclage was placed until 7 days later
measure: Rate of Delivery at later than 34 weeks of pregnancy
timeFrame: Time frame measured from the time the patient reaches 34 weeks 1 day of pregnancy until birth
measure: Rate of a positive VF test results in association with adverse maternal and perinatal outcomes.
timeFrame: Time frame measured from the time of VF test until 28 days after delivery.
measure: Comparison of AF Test and VF Test results in prediction of a positive amniotic fluid culture
timeFrame: Time frame measured at the time of the amniocentesis
Other outcomes:
Locations:
Study officials:
affiliation: Pediatrix
name: Jeroen Vanderhoeven, MD
role: PRINCIPAL_INVESTIGATOR
References: