A Study to Evaluate the Use of Placenta Protein 13 (PP13)... | NCT00572793

Official Title

A Nested Case-Controlled Study Evaluating the Utility of Placental Protein 13 (PP13) In-vitro Diagnostic Kit as a Diagnostic Aiding Tool in Assessment of the Risk for Developing Preeclampsia Necessitating Delivery Before 37 Weeks (Early-preeclampsia) Based on First Trimester Blood Testing of Pregnant Women With Low and Unknown Risk

Status Module

Record Verification Date

Jul 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

Nov 2007

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Dec 11, 2007

First Submission Date that Met QC Criteria

Dec 12, 2007

First Posted Date

Dec 13, 2007Estimated

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

Jul 7, 2015

Last Update Posted Date

Jul 8, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carl Weiner, MD, Professor and Chair, Obstetrics and Gynecology, University of Kansas Medical CenterSponsor-Investigator

Lead Sponsor

Carl Weiner, MDOTHER

Collaborators

Name	Class
Diagnostic Technologies Ltd.	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

The purpose of this study is to evaluate whether it is possible to detect changes in the concentration of PP13 in the blood of pregnant women who may go on to develop the complication of preeclampsia later on in the pregnancy, and if these changes can be detected early enough to allow early diagnosis and treatment for prevention of these complications and reduce their damage. This study will test if the PP13 biomarker during the first trimester of pregnancy has the ability to provide assessment of risk for the development of preeclampsia that necessitates delivery before 37 weeks gestation or can predict preeclampsia before 34 weeks gestation.

Detailed Description

After obtaining informed consent maternal demographics, vital signs, height, weight, medical history, pregnancy dating, dipstick for urine protein, previous lab results, nuchal translucency results and uterine artery Doppler results (if done) will be obtained. Blood for PP13 will be obtained at 7-13 weeks and optionally at 21-23 weeks. Hospitalization and delivery information will be obtained via a chart review for evidence of preeclampsia.

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

431Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preeclampsia necessitating delivery at gestational age < 37 weeks including HELLP syndrome and eclampsia		37 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Maternal and Neonatal morbidity and mortality and very early preeclampsia necessitating delivery before 34 weeks		34 Weeks, At Delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy, pregnant females
Singleton fetus at 7 0/7 to 13 6/7 weeks gestation

Exclusion Criteria:

Multi-fetal pregnancy
Mental retardation
Known fetal anomaly or demise
BMI > 35, serious medical condition

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Pregnant patients seen or referred to the obstetrical clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carl Weiner, MD, MBA	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center		Kansas City	Kansas	66160	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases