title: Serum biomarkers may help predict successful misoprostol management of early pregnancy failure.
abstract: In order to simplify management of early pregnancy loss, our goal was to elucidate predictors of successful medical management of miscarriage with a single dose of misoprostol. In this secondary analysis of data from a multicenter randomized controlled trial, candidate biomarkers were compared between 49 women with missed abortion who succeeded in passing their pregnancy with a single dose of misoprostol and 46 women who did not pass their pregnancy with a misoprostol single dose. We computed the precision of trophoblastic protein and hormone concentrations to discriminate between women who succeed or fail single dose misoprostol management. We also included demographic factors in our analyses. We found overlap in the concentrations of the individual markers between women who succeeded and failed single-dose misoprostol. However, hCG levels ≥ 4000 mIU/mL and ADAM-12 levels ≥ 2500 pg/mL were independently associated with complete uterine expulsion after one dose of misoprostol in our population. A multivariable logistic model for success included non-Hispanic ethnicity and parity <2 in addition to hCG ≥ 4000 mIU/mL and ADAM-12 ≥ 2500 pg/mL and had an area under the receiver operating characteristic (ROC) of 0.81 (95% confidence interval: 72-90%). Categorizing women with a predicted probability of ≥ 0.65 resulted in a sensitivity of 75.0%, specificity 77.1% and positive predictive value of 81.8%. While preliminary, our data suggest that serum biomarkers, especially when combined with demographic characteristics, may be helpful in guiding patient decision-making regarding the management of early pregnancy failure (EPF). Further study is warranted.
authors.affiliation: Penn Family Planning and Pregnancy Loss Center, Penn Medicine, University of Pennsylvania, Perelman School of Medicine, 1000 Courtyard, 3400 Spruce Street, Philadelphia, PA 19104, United States. Electronic address: schreibe@upenn.edu.
authors.forename: Courtney A
authors.initials: CA
authors.lastname: Schreiber
authors.affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Perelman School of Medicine, United States.
authors.forename: Sarah J
authors.initials: SJ
authors.lastname: Ratcliffe
authors.affiliation: Highland General Hospital | Alameda County Health System, United States.
authors.forename: Kelly E
authors.initials: KE
authors.lastname: Quinley
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, United States.
authors.forename: Carrie
authors.initials: C
authors.lastname: Miller
authors.affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Perelman School of Medicine, United States.
authors.forename: Mary D
authors.initials: MD
authors.lastname: Sammel
mesh_terms: D051722:ADAM Proteins / Q000097:blood*; D000072199:ADAM12 Protein; D000027:Abortion, Incomplete / Q000097:blood / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000209:etiology; D000030:Abortion, Missed / Q000188:drug therapy* / Q000503:physiopathology; D000282:Administration, Intravaginal; D000328:Adult; D015415:Biomarkers / Q000097:blood; D018997:Chorionic Gonadotropin, beta Subunit, Human / Q000097:blood*; D005260:Female; D006801:Humans; D016015:Logistic Models; D008565:Membrane Proteins / Q000097:blood*; D016595:Misoprostol / Q000008:administration & dosage / Q000627:therapeutic use*; D010120:Oxytocics / Q000008:administration & dosage / Q000627:therapeutic use*; D011237:Predictive Value of Tests; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D012372:ROC Curve; D012680:Sensitivity and Specificity; D013607:Tablets; D014463:Ultrasonography; D055815:Young Adult
chemical_list: D015415:Biomarkers; D018997:Chorionic Gonadotropin, beta Subunit, Human; D008565:Membrane Proteins; D010120:Oxytocics; D013607:Tablets; D016595:Misoprostol; D051722:ADAM Proteins; D000072199:ADAM12 Protein; C000606480:ADAM12 protein, human
keywords: Biomarkers; Early pregnancy failure; Miscarriage; Misoprostol; Pregnancy