Pregnancy
Conditions
Keywords
placental protein, gestational age, abortion
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.
Interventions
OTHERno intervention
no intervention, just specimen collection
Sponsors
Family Planning Associates Medical Group, LTD
Planned Parenthood of Greater New York
Presidential Women's Center
Gynuity Health Projects
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative Predictive Value 70 days | 1 day | Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤70 days is \>95% |
| Negative Predictive Value 105 days | 1 day | Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤105 days is \>95% |
Countries
United States
Outcome results
None listed