An observational study in Preterm Birth and Infection, sponsored by Pediatrix. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-27.
Sponsored by Pediatrix · Observational
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.
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.
Hospital based patients
Exclusion Criteria:
A vaginal fluid test of interleukin-6 (IL-6) and alphafetoprotein (AFP).
Also known as: vaginal fluid test.
Rate of very preterm birth (PTB)
Rate of Very PTB (PTB at less than 28 weeks of pregnancy)
Time frame: Time frame measured on the date of infant was born. We anticipate this time frame to be approximately 20 weeks.
Rate of Delivery within 7 days of cervical cerclage
Rate of Delivery within 7 days of cervical cerclage placement
Time frame: 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: 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: 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: Time frame measured at the time of the amniocentesis
No study locations are listed for this record.
Plan to share: Undecided — Not decided at this time
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Pediatrix