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

Gynuity Health Projects

Status: Terminated

Conditions: Pregnancy

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04232189

8003 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 275 patients

Sex: Female

Volunteers: No Healthy Volunteers

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