Urine beta-hCG (human Chorionic Gonadotropin) is a sensitive biomarker for detecting early pregnancy loss. However, the interpretation of daily hCG data involves investigator's judgment, even with several proposed algorithms to guide the assessment. To examine the reliability of hCG data interpretation, five experienced researchers independently assessed data from 153 menstrual cycles, determining whether each cycle represented no conception, a continuing conception, or a conception loss. The hCG levels were measured by immunoradiometric assay using a combination of antibodies for a beta subunit epitope (B109) and the intact heterodimer (B204). For each cycle, hCG data were presented as graphs of triplicate assays in a chart including cycle day and menstrual bleeding days.
Pairwise agreement among the assessors for any of the three options ranged from 54 to 86%. At least three experts agreed for 147 cycles (96%), accounting for 28 conception losses and 19 continuing conceptions. The multi-rater kappa was 0.63 for the conception lost category and 0.68 for continuing conceptions, indicating substantial agreement. The main sources of disagreement involved deciding whether there was sufficient information for assessment, interpreting cycle parameters such as cycle length or bleeding event, and interpreting a distinct hCG rise pattern below the baseline value obtained from the sterilized women.
Learning Objectives: The participant will be able to: 1. Discuss the methodology to detect early pregnancy loss 2. Discuss the sources of uncertainty in identifying early pregnancy loss
Keywords: Pregnancy Outcomes, Methodology
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.