VF Test for Prediction of Extremely PTB After Cerclage

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.

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