Unrecognized maternal heart rate artefact in cases of perinatal mortality reported to the United States Food and Drug Administration from 2009 to 2019: a critical patient safety issue
Bibliographic record
Abstract
BACKGROUND: Maternal heart rate artefact is a signal processing error whereby the fetal heart rate is masked by the maternal pulse, potentially leading to danger by failure to recognize an abnormal fetal heart rate or a pre-existing fetal death. Maternal heart rate artefact may be exacerbated by autocorrelation algorithms in modern fetal monitors due to smooth transitions between maternal and fetal heart rates rather than breaks in the tracing. In response, manufacturers of cardiotocography monitors recommend verifying fetal life prior to monitoring and have developed safeguards including signal ambiguity detection technologies to simultaneously and continuously monitor the maternal and fetal heart rates. However, these safeguards are not emphasized in current cardiotocography clinical practice guidelines, potentially leading to a patient safety gap. METHODS: The United States Food and Drug Administration Manufacturer and User Facility Device Experience database was reviewed for records with event type "Death" for the time period March 31, 2009 to March 31, 2019, in combination with search terms selected to capture all cases reported involving cardiotocography devices. Records were reviewed to determine whether maternal heart rate artefact was probable and/or whether the report contained a recommendation from the device manufacturer regarding maternal heart rate artefact. RESULTS: Forty-seven cases of perinatal mortality were identified with probable maternal heart rate artefact including 14 with antepartum fetal death prior to initiation of cardiotocography, 14 with intrapartum fetal death or neonatal death after initiation of cardiotocography, and 19 where the temporal relationship between initiation of cardiotocography and death cannot be definitively established from the report. In 29 cases, there was a recommendation from the manufacturer regarding diagnosis and/or management of maternal heart rate artefact. CONCLUSIONS: This case series indicates a recurring problem with undetected maternal heart rate artefact leading to perinatal mortality and, in cases of pre-existing fetal death, healthcare provider confusion. In response, manufacturers frequently recommend safeguards which are found in their device's instructions for use but not in major intrapartum cardiotocography guidelines. Cardiotocography guidelines should be updated to include the latest safeguards against the risks of maternal heart rate artefact. An additional file summarizing key points for clinicians is included.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.018 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.004 | 0.004 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".