The Italian Obstetric Surveillance System (ItOSS)

Severe maternal morbidity

Maternal near-miss and severe maternal morbidity are different ways of referring to serious obstetric complications that are potentially life-threatening. The World Health Organization (WHO) defines a near-miss case as a woman «who nearly died but survived a complication that occurred during pregnancy, childbirth or within 42 days of termination of pregnancy» [1]. Analyzing the causes and healthcare procedures that helped prevent the death of a woman can provide valuable information when assessing clinical and organizational appropriateness [2]. A near-miss represents “successful treatment” and facilitates auditing and critical review of clinical pathways, which may be particularly difficult for clinicians in the case of maternal death. In socially advanced countries, the higher rate of near-miss cases compared to maternal deaths allows a much faster evaluation of the outcomes of interest, thus accelerating the implementation of good practices.

In Europe, severe morbid events related to maternity care were estimated at between 9 and 16 cases per 1000 maternities [3]. In 2012, the Italian Obstetric Surveillance System (ItOSS) conducted a retrospective study using hospital discharge records (Schede di Dimissione Ospedaliera - SDO) to estimate the maternal near-miss ratio [4] for the purpose of quantifying the phenomenon and describing the main causes of severe morbid events. In 2014, ItOSS launched the first prospective population-based study of maternal near-miss incident cases due to haemorrhage with a view to gathering useful information for clinical practice [5,6,7]. The study produced the first Italian population-based incidence rates of severe postpartum haemorrhage and other serious haemorrhagic conditions – abnormally invasive placenta, uterine rupture and peripartum hysterectomy – which are the leading causes of severe maternal morbidity and mortality in Italy. An analysis of the results allowed retracing the clinical pathway for all cases, identifying the organizational and clinical problems that need to be addressed to prevent avoidable outcomes, and facilitating continuing professional development of healthcare workers providing pregnancy and childbirth care.

The 2016 project - Maternal near-miss cases in Italy: sepsis, eclampsia, amniotic fluid embolism and spontaneous haemoperitoneum

The population-based project, coordinated by region Lombardy in collaboration with ItOSS and eight other regions (Piedmont, Friuli Venezia Giulia, Emilia-Romagna, Tuscany, Lazio, Campania, Apulia and Sicily), collects information on maternal near-miss incident cases due to sepsis, eclampsia, amniotic fluid embolism and spontaneous haemoperitoneum. The ISS-Regions surveillance system of maternal mortality shows that sepsis, hypertensive disorders of pregnancy and thromboembolism (in order of frequency), together with haemorrhagic emergencies, account for about 75% of maternal deaths. In socially advanced countries, it is estimated that about 50% of maternal deaths could be prevented and severe maternal morbidity could be reduced by improving healthcare standards. Italian data are therefore urgently needed to help prevent avoidable adverse outcomes.

Sepsis (a known or suspected maternal infection associated with dysfunction of one or more organs) is an emerging condition in terms of global incidence and, partly due to its high case fatality rate, is currently the focus of a WHO-coordinated international effort aimed at improving its management and reducing its avoidable burden. (See also the page dedicated to Maternal and perinatal sepsis)

Eclampsia (the onset of seizures during pregnancy or after childbirth associated with at least one of the following signs: hypertension, presence of proteins in the urine or altered transaminase levels or platelet counts) is another serious complication linked to hypertensive disorders in pregnancy, childbirth and the puerperium. Collecting data in Italy will allow evaluating appropriateness of care in response to this obstetric emergency, in order to prevent avoidable cases, facilitate early diagnosis and promote proper treatment.

Amniotic fluid embolism (maternal acute cardiorespiratory collapse occurring within few hours of labour, childbirth or rupture of membranes, due to entry of amniotic fluid into the maternal circulation) and spontaneous haemoperitoneum (internal haemorrhage from a non-traumatic cause) are two very rare obstetric conditions with high case fatality rates. Amniotic fluid embolism is difficult to diagnose and further study of incident cases will help improve diagnostic appropriateness. Spontaneous haemoperitoneum is a potentially life-threatening condition for both mother and foetus, and estimating its incidence is currently very difficult.

The project includes an accredited CME (continuing medical education) e-learning course (ITA) on sepsis, identified by the Obstetric Surveillance System as an emerging condition on which continuing professional education of healthcare workers is needed.

Study population and procedure

The observational study involves collecting data on all incident cases of the conditions of interest occurring at any public or private birth facility across the participating regions. Information on the organizational characteristics of the participating healthcare facilities will also be collected to adjust for possible confounders related to the hospital case mix and organizational procedures in place at obstetric units. Incident cases will be reported and described via an online data entry system using an anonymous data collection form.

Importance of the project

A prospective population-based evaluation of the incident cases will allow, for the first time in Italy, estimating the incidence rates of the conditions in question, analyzing possible causes and clinical and/or organizational factors that contributed to the events, and therefore gathering specific information to help prevent avoidable severe morbidity.

The organization of multi-professional audits, in cooperation with the local and regional clinical risk network, will facilitate peer-to-peer exchange of views and promote a “no name, no blame” culture. A meeting will also be held at the end of the project to present and discuss the results with professionals of the National Health System.

References

1. World Health Organization. Evaluating the quality of care for severe pregnancy complications. The WHO near-miss approach for maternal health. Geneva: WHO; 2011.
2. Say L, Souza JP, Pattinson RC. WHO working group on Maternal Mortality and Morbidity classifications. Maternal near miss – towards a standard tool for monitoring quality of maternal health care. Best Pract Res Clin Obstet Gynaecol 2009; 23:287-96.
3. Peristat Monitoring and Evaluating Perinatal Health in Europe.
4. Donati S, Senatore S, Ronconi A, and the regional maternal mortality-working group. Obstetric near-miss cases among women admitted to intensive care units in Italy. Acta Obstet Gynecol Scand 2012, 91(4):452-7
5. Serena Donati, Alice Maraschini, Marta Buoncristiano, Ilaria Lega, Mauro Bucciarelli, Silvia Andreozzi, Gruppo di lavoro Istituto Superiore di Sanità-Regioni. Stato di salute e qualità dell’assistenza nelle regioni Italiane Attività della sorveglianza ostetrica: l’Istituto Superiore di Sanità-Regioni per la gestione della morbosità materna grave da emorragia del post partum. Rapporto Osservasalute 2015: p.264-66
6. Donati S, Maraschini A, Lega I, D’Aloja P; Maternal near miss due to postpartum haemorrhage: Prospective population-based data from the 2014–2016 Italian Obstetric Surveillance System (ItOSS) study. Eur. J. Obstet. Gynecol. Reprod. Biol. 2019; 234, Page e154
7. Lewis G. Saving Mothers' Lives: The Continuing Benefits for Maternal Health From the United Kingdom (UK) Confidential Enquires Into Maternal Deaths. Semin Perinatol 2012;36:19-26.