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NCT04232189 Clinical Trial

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

Pregnancy Clinical Trial

Official title:
Serum Concentrations of Pregnancy-associated Proteins for Assessment of Gestational Age Before Abortion

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04232189
Other study ID # 8003
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 12, 2019
Est. completion date April 14, 2020

Study information
Verified date July 2021
Source Gynuity Health Projects
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 275
Est. completion date April 14, 2020
Est. primary completion date April 14, 2020
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
no intervention, just specimen collection

Locations
Country Name City State
United States Family Planning Associates Chicago Illinois
United States Planned Parenthood of New York City New York New York
United States Presidential Women's Center West Palm Beach Florida

Sponsors (4)
Lead Sponsor Collaborator
Gynuity Health Projects Family Planning Associates Medical Group, LTD, Planned Parenthood of Greater New York, Presidential Women's Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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