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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-12

Study Completion Date

2020-04-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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no intervention

no intervention, just specimen collection

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No