Screening To Obviate Preterm Birth | NCT01868308

Studies
Screening To Obviate Preterm Birth

NCT01868308

Sponsor

University of Pennsylvania

Status

Completed

Last Update Posted

Mar 30, 2017Actual

Enrollment

589Actual

Phase

Not provided

Conditions

Preterm Labor
Preterm Contractions
Abdominal Cramping
Back Pain
Vaginal Pressure
Vaginal Bleeding

Interventions

Not provided

Countries

United States

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

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Feb 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

May 29, 2013

First Submission Date that Met QC Criteria

Jun 3, 2013

First Posted Date

Jun 4, 2013Estimated

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

Mar 28, 2017

Last Update Posted Date

Mar 30, 2017Actual

Name	Class
Hologic, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Our objective is to investigate the predictive value of a panel of biomarkers associated with two biologically plausible pathways of preterm birth: membrane breakdown and cervical remodeling. The investigators will obtain cervical length, cervicovaginal fetal fibronectin, and a panel of novel cervicovaginal biomarkers associated with cervical remodeling in a prospective cohort of symptomatic women with a singleton pregnancy at high risk for preterm birth in an effort to better risk stratify this cohort.

Detailed Description

Preterm Birth is a complex syndrome for which several different biologically plausible pathways have been proposed, including mechanical uterine distension, abruption, inflammation, and/or activation of the fetal hypothalamic-pituitary-axis. However, despite our knowing the complexity of this syndrome and the different pathways involved, there is a paucity of clinical studies investigating whether detection of more than one of these pathways in a single patient might enhance the identification of those at greatest risk for preterm birth. We propose investigating the predictive value of a panel of biomarkers associated with two biological plausible pathways - membrane breakdown and cervical remodeling - that must be involved in the pathogenesis of preterm birth. Specifically, we propose measuring cervical length and collecting cervicovaginal fetal fibronectin as well as a panel of novel cervicovaginal biomarkers that reflect molecular pathways involved in cervical remodeling in a prospectively collected cohort of symptomatic women with singleton fetuses at high risk for preterm birth. Through this study we hope improve risk stratification of this high risk cohort.

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

Retention

Enrollment

589Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preterm Labor		Symptomatic women with singleton pregnancy at high risk for preterm birth between 22 - 33 6/7 weeks gestational age. We define "high risk for preterm birth" as women who present to our triage unit with complaints of preterm labor, including but not limited to preterm contractions, abdominal cramping, back pain, vaginal pressure, and vaginal bleeding.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preterm birth	The primary outcome is preterm birth defined as delivery before 37 weeks.	Enrollment through delivery

Secondary Outcomes

Measure	Description	Time Frame
Early preterm birth	The secondary outcome is "early" preterm birth defined as delivery before 34 weeks.	Enrollment through delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton pregnancy between 22- 33 6/7 weeks of gestational age.
Must be experiencing one ore more of the following symptoms including but not limited to preterm contractions, abdominal cramping, back pain, vaginal pressure, or light vaginal bleeding.

Exclusion Criteria:

Women with a multi-fetal pregnancy
Intra uterine fetal demise
Preterm premature rupture of membranes
Overt chorioamnionitis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All pregnant women presenting to the perinatal evaluation center at the Hospital of the University of Pennsylvania with preterm labor symptoms will be approached for the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michal A Elovitz, MD	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

Condition Browse Module

MeSH Terms

ID	Term
D007752	Obstetric Labor, Premature
D003085	Colic
D001416	Back Pain
D014592	Uterine Hemorrhage

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

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Browse Branches

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