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

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.

Study Overview

• Status: Terminated
• Conditions: Pregnancy
• Intervention / Treatment: Other: no intervention

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 Type: Observational
• Enrollment (Actual): 275

Contacts and Locations

Study Locations

• United States
  • Florida
    • West Palm Beach, Florida, United States, 33407
      • Presidential Women's Center
  • Illinois
    • Chicago, Illinois, United States, 60661
      • Family Planning Associates
  • New York
    • New York, New York, United States, 10012
      • Planned Parenthood of New York City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant people seeking abortion at multiple clinics that provide abortion through at least 18 weeks of gestation.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Planned Parenthood of Greater New York; Family Planning Associates Medical Group, LTD; Presidential Women's Center
• Investigators: Principal Investigator: Elizabeth G Raymond, MD, Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): April 14, 2020
• Study Completion (Actual): April 14, 2020

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: abortion; gestational age; placental protein
• Other Study ID Numbers: 8003 (Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No