Abstract
Objective
To examine the possibility that serum or urine concentrations of pregnancy-associated
plasma protein A (PAPP-A), a disintegrin and metalloproteinase 12 (ADAM-12), placental
growth factor (PlGF), human placental lactogen (HPL), glypican-3, pregnancy specific
beta-1-glycoprotein 1 (PSG-1) or prolactin could predict gestational age (GA) >70 days,
the currently recommended limit for medical abortion in the United States.
Study design
In this exploratory observational study, we collected serum and urine specimens from
245 healthy individuals with singleton intrauterine pregnancies at GA <40 weeks by
ultrasound. We assayed the serum specimens for all seven proteins and the urine specimens
for PAPP-A and ADAM-12. We used scatterplots and receiver operating characteristic
curves to identify a concentration for each protein that would differentiate GAs above
and below 70 days.
Results
All seven proteins showed significant ability to distinguish GAs >70 days from earlier
gestations. A PAPP-A concentration ≥5.591 ng/ml provided 100% sensitivity and 90%
specificity for identifying GAs >70 days. An ADAM-12 concentration of ≥3.11 ng/ml
provided 98.5% sensitivity and 77% specificity for identifying GAs >70 days. Serum
concentrations of the other compounds showed less diagnostic discrimination. PAPP-A
was not detected in urine, and urinary ADAM-12 concentrations were not useful in identifying
GAs above 70 days.
Conclusion
PAPP-A and ADAM-12 showed considerable promise as bases for a sensitive and specific
serum test for identifying pregnancies with GA >70 days. If these results are confirmed
by future research, such a test could obviate the need for routine ultrasound before
medical abortion.
Implications
Two placental proteins, PAPP-A and ADAM-12, showed considerable promise as bases for
a serum test for identifying pregnancies with gestational age >70 days. Such a test
could be highly useful in screening patients for eligibility for medical abortion.
Keywords
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Article info
Publication history
Published online: January 31, 2020
Accepted:
January 15,
2020
Received in revised form:
January 7,
2020
Received:
October 7,
2019
Footnotes
☆Financial support: This work was supported by an anonymous donor and a grant to Dr. Barnhart from the National Institute of Child Health and Human Development (R01HD076279). The funders had no role in the study design, in the collection, analysis and interpretation of data, in the writing of the report, or in the decision to submit the article for publication.
☆☆None of the authors has any conflict of interest.
★The findings and conclusions in this article are those of the authors and do not necessarily represent the views of Planned Parenthood Federation of America, Inc. Preliminary findings were presented at the following venues: Annual Mifepristone Meeting June 2018, Gynuity Health Projects, New York, NY; National Abortion Federation Annual Meeting April 2019, Chicago, IL. The full study protocol is stored at Gynuity Health Projects. No data or additional related documents from this study will be available.
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© 2020 Elsevier Inc. All rights reserved.
