An observational study in Pregnancy, sponsored by Gynuity Health Projects. Terminated at 3 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2021-07-23.
Sponsored by Gynuity Health Projects · Observational
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.
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.
Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant people seeking abortion at multiple clinics that provide abortion through at least 18 weeks of gestation.
Exclusion Criteria:
no intervention, just specimen collection
Negative Predictive Value 70 days
Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤70 days is \>95%
Time frame: 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%
Time frame: 1 day
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Gynuity Health Projects