VF Test for Prediction of Extremely PTB After Cerclage | NCT03443154

Studies
VF Test for Prediction of Extremely PTB After Cerclage

NCT03443154

Sponsor

Pediatrix

Status

Withdrawn

Last Update Posted

Jun 27, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Preterm Birth
Infection

Interventions

VF-Test

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Industry sponsor withdrew financial support as well as the testing equipment.

Expanded Access Info

Start Date

Jun 2018Estimated

Primary Completion Date

Jun 1, 2018Actual

Completion Date

Jun 1, 2018Actual

First Submitted Date

Feb 16, 2018

First Submission Date that Met QC Criteria

Feb 16, 2018

First Posted Date

Feb 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2018

Last Update Posted Date

Jun 27, 2018Actual

Name	Class
Hologic, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VF-Test	Diagnostic Test	A vaginal fluid test of interleukin-6 (IL-6) and alphafetoprotein (AFP).		vaginal fluid test.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hospital based patients

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Jeroen Vanderhoeven, MD	Pediatrix	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not decided at this time

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D007239	Infections

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

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Browse Branches

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