Limitations in the recording of maternal mortality in Germany: An analysis of statistical challenges

Background: The World Health Organization (WHO) defines maternal mortality as the death of a woman during pregnancy or up to 42 days after delivery. The maternal mortality ratio (MMR) serves as an indicator of the quality of health care. In Germany, recording is based on the death certificate (ICD-10 code), with variations in documentation leading to underreporting. Studies indicate insufficient data in Berlin and queries in Germany. Method: 2,316 death certificates of women (aged 15 – 50) from the Berlin Central Archive (2019 – 2022) were analysed to identify maternal deaths and the quality of the information provided was assessed. In addition, the recording of pregnancy status on death certificates was examined nationwide. Results: Fourteen maternal deaths (excluding late cases according to the WHO) were identified. Only four cases were identifiable as maternal deaths solely on the basis of ICD-10 codes. The additional information ‘Is or was the woman pregnant?’ which is important for identification, was available in about a quarter of the death certificates reviewed. In 73.2 % of cases, the question ‘Is or was the woman pregnant?’ remained unanswered. A nationwide comparison of death certificates revealed considerable differences: only Bavaria and Bremen followed the WHO definition. Saxony-Anhalt does not record pregnancy status at all. Conclusion: The recording of maternal mortality in Germany is incomplete. Death certificates are often deficient. Many federal states record periods outside the WHO definition (3 –12 months after birth). A standardized national system for registering maternal deaths is required to improve data collection and enable better prevention.Peer Reviewe

Erfassungsdefizite bei der Müttersterblichkeit in Deutschland: Eine Analyse statistischer Herausforderungen

Hintergrund: Die Weltgesundheitsorganisation (WHO) definiert Müttersterblichkeit als den Tod einer Frau während der Schwangerschaft oder bis 42 Tage danach. Die maternale Mortalitätsrate (MMR) dient als Indikator für die Qualität der Gesundheitsversorgung. In Deutschland basiert die Erfassung auf dem Leichenschauschein (ICD-10-Code), wobei Variationen in der Dokumentation zu Untererfassung führen. Studien deuten auf unzureichende Angaben in Berlin und Abfragen in Deutschland hin. Methode: Es wurden 2.316 Leichenschauscheine von Frauen (15 – 50 Jahre) aus dem Berliner Zentralarchiv (2019 – 2022) zur Identifikation mütterlicher Todesfälle analysiert und die Ausfüllqualität bewertet. Zudem wurde bundesweit die Erfassung des Schwangerschaftsstatus auf den Leichenschauscheinen untersucht. Ergebnisse: 14 maternale Todesfälle (ohne späte Fälle laut WHO) wurden identifiziert. Nur vier Fälle waren allein durch ICD-10-Codes als mütterliche Todesfälle erkennbar. Die für die Identifikation wichtige Zusatzangabe „Ist oder war die Frau schwanger?“ war bei etwa einem Viertel der gesichteten Leichenschauscheine verfügbar. In 73,2 % der Fälle blieb die Frage „Ist oder war die Frau schwanger?“ unbeantwortet. Der bundesweite Vergleich der Leichenschauscheine zeigte erhebliche Unterschiede: Nur Bayern und Bremen folgten der WHO-Definition. Sachsen- Anhalt erfasst den Schwangerschaftsstatus gar nicht. Schlussfolgerung: Die Erfassung der Müttersterblichkeit in Deutschland ist lückenhaft. Leichenschauscheine sind häufig unvollständig ausgefüllt. Viele Bundesländer erfassen Zeiträume außerhalb der WHO-Definition (3 –12 Monate nach Geburt). Ein standardisiertes nationales System zur Registrierung von mütterlichen Todesfällen ist nötig, um die Datenerhebung zu verbessern und eine bessere Prävention zu ermöglichen.Peer Reviewe

HE4 as a serum biomarker for the diagnosis of pelvic masses: a prospective, multicenter study in 965 patients

Background: To evaluate the diagnostic value of adding human epididymis protein 4 (HE4), cancer antigen 125 (CA125) and risk of malignancy algorithm (ROMA) to ultrasound for detecting ovarian cancer in patients with a pelvic mass. Methods: This was a prospective, observational, multicenter study. Patients aged > 18 years who were scheduled to undergo surgery for a suspicious pelvic mass had CA125 and HE4 levels measured prior to surgery, in addition to a routine transvaginal ultrasound scan. The diagnostic performance of CA125, HE4 and ROMA for distinguishing between benign and malignant adnexal masses was assessed using receiver operating characteristic (ROC) analysis and the corresponding area under the curve (AUC). Results: Of 965 evaluable patients, 804 were diagnosed with benign tumors and 161 were diagnosed with ovarian cancer. In late-stage ovarian cancer, CA125, HE4 and ROMA all had an excellent diagnostic performance (AUC > 0.92), whereas in stage I and II, diagnostic performance of all three biomarkers was less adequate (AUC < 0.77). In the differential diagnosis of ovarian cancer and endometriosis, ROMA and HE4 performed better than CA125 with 99 and 98.1% versus 75.0% sensitivity, respectively, at 75.4% specificity. Conclusions: ROMA and HE4 could be valuable biomarkers to help with the diagnosis of ovarian cancer in premenopausal patients in order to differentiate from endometriosis, whereas CA125 may be more adequate for postmenopausal patients

Risk factors associated with adverse fetal outcomes in pregnancies affected by Coronavirus disease 2019 (COVID-19): a secondary analysis of the WAPM study on COVID-19.

Objectives To evaluate the strength of association between maternal and pregnancy characteristics and the risk of adverse perinatal outcomes in pregnancies with laboratory confirmed COVID-19. Methods Secondary analysis of a multinational, cohort study on all consecutive pregnant women with laboratory-confirmed COVID-19 from February 1, 2020 to April 30, 2020 from 73 centers from 22 different countries. A confirmed case of COVID-19 was defined as a positive result on real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens. The primary outcome was a composite adverse fetal outcome, defined as the presence of either abortion (pregnancy loss before 22 weeks of gestations), stillbirth (intrauterine fetal death after 22 weeks of gestation), neonatal death (death of a live-born infant within the first 28 days of life), and perinatal death (either stillbirth or neonatal death). Logistic regression analysis was performed to evaluate parameters independently associated with the primary outcome. Logistic regression was reported as odds ratio (OR) with 95% confidence interval (CI). Results Mean gestational age at diagnosis was 30.6+/-9.5 weeks, with 8.0% of women being diagnosed in the first, 22.2% in the second and 69.8% in the third trimester of pregnancy. There were six miscarriage (2.3%), six intrauterine device (IUD) (2.3) and 5 (2.0%) neonatal deaths, with an overall rate of perinatal death of 4.2% (11/265), thus resulting into 17 cases experiencing and 226 not experiencing composite adverse fetal outcome. Neither stillbirths nor neonatal deaths had congenital anomalies found at antenatal or postnatal evaluation. Furthermore, none of the cases experiencing IUD had signs of impending demise at arterial or venous Doppler. Neonatal deaths were all considered as prematurity-related adverse events. Of the 250 live-born neonates, one (0.4%) was found positive at RT-PCR pharyngeal swabs performed after delivery. The mother was tested positive during the third trimester of pregnancy. The newborn was asymptomatic and had negative RT-PCR test after 14 days of life. At logistic regression analysis, gestational age at diagnosis (OR: 0.85, 95% CI 0.8-0.9 per week increase; pPeer reviewe

Maternal and perinatal outcomes of pregnant women with SARS-CoV-2 infection.

OBJECTIVES: To evaluate the maternal and perinatal outcomes of pregnancies affected by SARS-CoV-2 infection. METHODS: This was a multinational retrospective cohort study including women with a singleton pregnancy and laboratory-confirmed SARS-CoV-2 infection, conducted in 72 centers in 22 different countries in Europe, the USA, South America, Asia and Australia, between 1 February 2020 and 30 April 2020. Confirmed SARS-CoV-2 infection was defined as a positive result on real-time reverse-transcription polymerase chain reaction (RT-PCR) assay of nasopharyngeal swab specimens. The primary outcome was a composite measure of maternal mortality and morbidity, including admission to the intensive care unit (ICU), use of mechanical ventilation and death. RESULTS: In total, 388 women with a singleton pregnancy tested positive for SARS-CoV-2 on RT-PCR of a nasopharyngeal swab and were included in the study. Composite adverse maternal outcome was observed in 47/388 (12.1%) women; 43 (11.1%) women were admitted to the ICU, 36 (9.3%) required mechanical ventilation and three (0.8%) died. Of the 388 women included in the study, 122 (31.4%) were still pregnant at the time of data analysis. Among the other 266 women, six (19.4% of the 31 women with first-trimester infection) had miscarriage, three (1.1%) had termination of pregnancy, six (2.3%) had stillbirth and 251 (94.4%) delivered a liveborn infant. The rate of preterm birth before 37 weeks' gestation was 26.3% (70/266). Of the 251 liveborn infants, 69/251 (27.5%) were admitted to the neonatal ICU, and there were five (2.0%) neonatal deaths. The overall rate of perinatal death was 4.1% (11/266). Only one (1/251, 0.4%) infant, born to a mother who tested positive during the third trimester, was found to be positive for SARS-CoV-2 on RT-PCR. CONCLUSIONS: SARS-CoV-2 infection in pregnant women is associated with a 0.8% rate of maternal mortality, but an 11.1% rate of admission to the ICU. The risk of vertical transmission seems to be negligible. © 2020 International Society of Ultrasound in Obstetrics and Gynecology

Maternal mortality in the city of Berlin: consequences for perinatal healthcare

Abstract Objectives The fifth of the United Nations’ Millennium Development Goals proposed for 2000–2015 was to improve maternal health, which has only partially been achieved. Worldwide, the maternal mortality ratio is currently estimated at 216/100.000 livebirths, compared to 380/100,000 in 1990. As yet, there has been no published comprehensive analysis of maternal mortality data as it pertains to Berlin and by extension Germany. Aim of the study was to evaluate and analyze the maternal mortality rate of Berlin as a result of shortcomings in healthcare provision and identify possible solutions. Methods The Institute for Quality and Transparency in the Healthcare Sector sourced external quality control from the Qualitätsbüro Berlin to provide maternal mortality data from Berlin hospitals from 2007 to 2020. Results Nineteen maternal deaths were registered between 2007 and 2020 in total. Case analysis shows that two main events occur: thrombosis and hemorrhage at 31.6%, respectively, followed by hypertensive disorder (15.8%), and sepsis (15.8%). After detailed analysis of each case report, we determined 8/19 (42.1%) maternal deaths as being potentially preventable given slightly altered circumstances. Conclusions The system of registration of perinatal data in Germany does not allow for a comprehensive recording of maternal death and requires alteration to provide a more accurate picture of the phenomenon of maternal mortality; presumably, there exist twice as many unreported cases. Symptoms, risks, and primary prevention tactics of thromboembolism during pregnancy and birth should be imparted to every licensed professional in individual hospital settings, along with evidence-based simulation training for the event of obstetric or prepartum hemorrhage. </jats:sec

Impact of fetal blood sampling on vaginal delivery and neonatal outcome in deliveries complicated by pathologic fetal heart rate: a population based cohort study

Objective: To compare the impact of electronic fetal monitoring (EFM) alone vs. EFM with additional fetal blood sampling (FBS) in vaginal deliveries complicated by pathologic fetal heart rate (FHR). Methods: All deliveries in Hesse between 1990 and 2000 were evaluated for participation in this study. Inclusion criteria comprised (1) pathologic fetal heart rate, (2) singleton pregnancy, (3) cephalic presentation, (4) vaginal delivery, and (5) gestational age at delivery of more than 35 weeks' gestation. In order to analyze the meaning of additional risk factors at birth for the effectiveness of FBS two subgroups were selected depending on the presence of additional risk factors at birth. To examine the impact of FIBS in deliveries with pathologic FHR on the mode of delivery and on neonatal outcome, univariate regression analysis was performed and odds ratios (OR) and their corresponding 95% confindence intervals (95% CI) were calculated. Results: The study population comprised 49,560 deliveries, among deliveries complicated by pathologic FHR, 26% underwent FBS. Deliveries with pathologic FHR and controlled by FBS, with no additional antepartum risk factors, were associated with an increase in spontaneous births OR 1.41 (95% CI 1.27-1.58), and in the presence of additional risk factors OR 1.24 (1.19-1.30). Short-term neonatal outcome parameters were characterized by a lower frequency of severe fetal acidosis (umbilical artery pH < 7.0) OR 0.55 (0.42-0.72), and Apgar score < 5 after 5 min, OR 0.71 (0.55-0.90). Conclusion: In vaginal deliveries with pathologic FHR the use of FIBS as an additional means of intrapartum fetal surveillance is associated with less vaginal operative deliveries, and with an improved short-term neonatal outcome