NCT03443154

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Pediatrix · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Birth
• Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	VF-Test	A vaginal fluid test of interleukin-6 (IL-6) and alphafetoprotein (AFP).

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2018-02-22
• Last updated: 2018-06-27