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

Terminated

• Conditions: Pregnancy

• Registration Number: NCT04232189
• Lead Sponsor: Gynuity Health Projects

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.

Study Timeline

• Study Start: 2019-11-12
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Primary Completion: 2020-04-14
• Study Completion: 2020-04-14
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 275

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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%
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%

Trial Locations

Locations (3)

Family Planning Associates; 🇺🇸 Chicago, Illinois, United States

Presidential Women's Center; 🇺🇸 West Palm Beach, Florida, United States

Planned Parenthood of New York City; 🇺🇸 New York, New York, United States