Proteomic Assessment of Preterm Birth | NCT01371019

Studies
Proteomic Assessment of Preterm Birth

NCT01371019

Sponsor

Sera Prognostics, Inc.

Status

Completed

Last Update Posted

Jun 11, 2015Estimated

Enrollment

5,500Actual

Phase

Not provided

Conditions

Preterm Birth

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

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

Apr 2011

Primary Completion Date

Dec 2014Actual

Completion Date

Apr 2015Actual

First Submitted Date

Jun 8, 2011

First Submission Date that Met QC Criteria

Jun 8, 2011

First Posted Date

Jun 10, 2011Estimated

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 9, 2015

Last Update Posted Date

Jun 11, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to to collect and store blood samples that will be utilized to develop a multimarker test to predict preterm delivery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

5,500Actual

Measure	Description	Time Frame
Spontaneous Preterm Birth		August 2015

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is 18 years or older.
Subject has a singleton pregnancy.
Subject is able to provide consent.

Exclusion Criteria:

Subject is pregnant with more than one fetus.
There is a known or suspected fetal anomaly.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Pregnant women who are receiving prenatal care.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Durlin E Hickok, MD, MPH	Sera Prognostics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maricopa Integrated Health System		Phoenix	Arizona	85008	United States
San Diego Perinatal Clinic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21074133	Background	Esplin MS, Merrell K, Goldenberg R, Lai Y, Iams JD, Mercer B, Spong CY, Miodovnik M, Simhan HN, van Dorsten P, Dombrowski M; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Proteomic identification of serum peptides predicting subsequent spontaneous preterm birth. Am J Obstet Gynecol. 2011 May;204(5):391.e1-8. doi: 10.1016/j.ajog.2010.09.021. Epub 2010 Nov 11.

Label	Type	Description	Intervention Names
Women with preterm delivery
Women without preterm delivery

Type	Date	Date Unknown
Release	Apr 12, 2021
Reset	May 5, 2021

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