Serum Concentrations of Pregnancy-associated Proteins for... | NCT04232189

Studies
Serum Concentrations of Pregnancy-associated Proteins for Assessment of Gestational Age Before Abortion

NCT04232189

Sponsor

Gynuity Health Projects

Status

Terminated

Last Update Posted

Jul 23, 2021Actual

Enrollment

275Actual

Phase

Not provided

Conditions

Pregnancy

Interventions

no intervention

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

Jul 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID 19 related recruitment problems

Expanded Access Info

Start Date

Nov 12, 2019Actual

Primary Completion Date

Apr 14, 2020Actual

Completion Date

Apr 14, 2020Actual

First Submitted Date

Jan 14, 2020

First Submission Date that Met QC Criteria

Jan 14, 2020

First Posted Date

Jan 18, 2020Actual

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 19, 2021

Last Update Posted Date

Jul 23, 2021Actual

Name	Class
Family Planning Associates Medical Group, LTD	OTHER
Planned Parenthood of Greater New York	OTHER
Presidential Women's Center	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This will be a case-series multicenter study enrolling 800 pregnant people. Serum will be collected from people seeking abortion and assayed at a qualified laboratory.

Detailed Description

Knowledge of gestational age (GA) is essential for guiding abortion care. In 2016, Gynuity Health Projects (GHP) launched a portfolio of research that aims to explore the possibility of developing a blood or urine test for this purpose.The goal of the present study is to validate initial study findings (protocol 8000) in a larger population of people seeking abortion.

Staff will obtain a serum specimen from each participant before any cervical manipulation is performed and before any abortifacient drug is administered. The site will send the specimens to a central facility for storage until assay. Serum assays for PAPP-A and possibly other proteins will be performed at a selected laboratory by qualified experts.

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

275Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention, just specimen collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Negative Predictive Value 70 days	Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤70 days is >95%	1 day
Negative Predictive Value 105 days	Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤105 days is >95%	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant and seeking medical or surgical abortion
Has had or will have an ultrasound on the day of study enrollment or earlier during the current pregnancy
Able to provide blood and urine specimens before any trans-cervical procedure or mifepristone ingestion
Not previously enrolled in this study

Exclusion Criteria:

Does not meet Inclusion Criteria

Accepts Healthy Volunteers

Not provided

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

Pregnant people seeking abortion at multiple clinics that provide abortion through at least 18 weeks of gestation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth G Raymond, MD	Gynuity Health Projects	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Presidential Women's Center		West Palm Beach	Florida	33407	United States
Family Planning Associates

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37038980	Derived	Frye LJ, Buhimschi IA, Raymond EG, Zhao G, Winikoff B. PAPP-A as a screening tool for assessment of gestational age before medication abortion in an intended-use population. Biomark Med. 2023 Jan;17(2):73-85. doi: 10.2217/bmm-2022-0653. Epub 2023 Apr 11.