The COVID-19 pandemic has seen almost 500 million people infected with the disease, including more than 6 million deaths globally [1]; it has also caused a global health, social, and economic crisis, with negative effects on the general population. Lockdown measures imposed to curb the spread of the infection [2] led to physical and emotional isolation, and this resulted in a global situation of uncertainty and psychological distress [3-5].

The COVID-19 pandemic also had collateral effects on mental health [6,7], with an increase in mental disorders in the general population [8] and mainly affecting the most vulnerable [9]. There are indeed indications that the adverse effects of health and social disasters are greater among vulnerable groups, such as the perinatal population [10]. The perinatal population is particularly vulnerable [11-13]—the period from conception to pregnancy and postpartum, which involves physiological, psychological, and social changes [14-16] and presents complex challenges for women [17] and men [18] who “transition to parenthood” [19]. Screenings over the prenatal and postnatal period [20] demonstrate that parents (mothers and fathers) may experience affective disorders [21] such as anxiety [22,23] and depression [24,25], also with comorbidity [26], with the risk of negative consequences for the mother’s health (eg, risks of miscarriage, pre-eclampsia, and gestational hypertension), and negative effects on the child’s development (premature birth; lower appearance, pulse, grimace, activity, and respiration scores; and low birth weight) [27] and on parents-infant relationships [28-30].

Due to the COVID-19 pandemic, these risk factors increased in the perinatal period; there were interruptions to the provision of perinatal health care services and changes to their structure [31,32]. During pregnancy, checkups and many routine outpatient visits were canceled [33,34], and there was a reduction in obstetric and psychological follow-ups. Delivery procedures during the pandemic also changed [35], with fathers not allowed to assist during labor. Lockdown and social isolation, together with restricted visits to maternity wards during hospitalization, in an effort to limit the risk of transmission of the virus, which reduced contact with family members, increased the negative psychological impact on the mother due to the lack of perceived social support [36,37]. Social support from the partner was also affected [38,39], as fathers were almost always not allowed to accompany mothers for checkups in health care centers. Preterm newborns were isolated from their mothers and fathers in the neonatal intensive care unit [40]. The pandemic restrictions also affected the immediate postpartum period, with interruptions in early dyadic relationships, particularly in mother-infant attachment [41]. International literature on COVID-19 effects reports mental health implications and distress in women during pregnancy [42], delivery, and postpartum [38,43], with an increasing prevalence of perinatal depression, anxiety [44-46], and posttraumatic stress disorders [47]. Pregnant mothers’ anxiety of attending checkups in clinics during routine prenatal care, due to the fear of being infected by SARS-CoV-2, and uncertainty about the effect of the virus on the fetus and infant, led to the postponing or cancelling of routine medical health care appointments [48], even though there was no consistent evidence of potential vertical intrauterine transmission of COVID-19 from mother to fetus [49,50]. The data collected by international researchers are controversial due to the lack of knowledge about the virus, which has generated many uncertainties about its long-term effects.

During the pandemic health emergency, maternal and fetal outcomes worsened globally, although there are limited data indicating that SARS-CoV-2 infection caused higher levels of adverse perinatal outcomes [51,52], measured in infected pregnant women compared to noninfected pregnant women [53]. Adverse outcomes include increased risks of perinatal loss [54,55]. Perinatal loss, that is, miscarriage (>20 weeks), stillbirth (>20 weeks gestation), or neonatal death (newborn in the first 28 days of life) [56], is an unexpected and complex negative life event, an experience that has always been poorly investigated. If we consider the period prior to the COVID-19 pandemic, more than 2 million perinatal deaths (stillbirths) and 2.9 million neonatal deaths occur worldwide every year [57]. However, The Lancet reports that not all of these deaths are recorded [58], and in the countries where the highest mortality occurs, the cause of these deaths is often not even identified. It should be noted that this high incidence has an economic impact on both global health and social systems [59]. Only recently did the World Health Organization [60] issue an operational guide to Maternal and Perinatal Death Surveillance and Response.

Perinatal death causes grief for the parental couple, requiring bereavement care [61]. In the international literature, “perinatal loss” refers to the death of the child in the perinatal period, but the term “loss” does not describe the parents’ state of mind and the complex psychological aspects of their suffering caused by this death. Perinatal loss is a painful and traumatic experience that can negatively affect a couple’s life; when the child dies, the plans for a new arrival in the family are abruptly halted, and the couple must process their mourning [62-65]. This interior processing of the grief over death is a necessary event, and the extent of their suffering depends on the affective investment of the parental couple in the child [66-69].

The possible negative consequences in terms of parental health can include affective disorders, such as anxiety, depressive, psychosomatic, and posttraumatic stress disorders [70]. Bereavement can lead to a crisis of faith [71], and the literature confirms that this can also occur in perinatal loss [72,73]. Perinatal loss is a biologically negative event, a particularly inexplicable experience; in the order of life events, children outlive their parents, hence the suffering of bereaved parents. Spirituality can serve as a coping mechanism to soften the complex painful feelings by helping mourners adapt to loss, and spiritual practices have been associated with better adjustment after the death of a child [71]. In a recent Italian study involving women who have experienced perinatal loss, it was found that religion helps them to accept grief and give meaning to such a tragedy [61].

There is a strong emotional impact also on the health care professionals working in maternity units [72,74]. It is important that these professionals understand parental perceptions to prevent the onset of psychopathologies, as perinatal mortality is an experience in which the early activation of the grief process is exacerbated by the circumstances surrounding this event [75].

During the pandemic period, mothers and fathers who suffered a perinatal loss found themselves experiencing further problems relating to COVID-19 [76], with the associated difficulties of the health system. Inpatient care for perinatal loss consists of bereavement care [77] according to specific clinical guidelines [78,79], which health care professionals were unable to follow during the pandemic to support parents. COVID-19 restrictions affected the provision of bereavement care compared to the period before the pandemic [80]. Personal protective equipment also prevented expressions of empathy from the operators, and support by means of physical contact was no longer permitted. There was also no time to train health workers adequately so that they could deal with the changes appropriately. These changes in care caused resentment among parents [81] and raised concerns over the possible negative impact on the long-term mourning process for parents and families [82] and increased risk of complicated grief [83].

The University of Padova and the University of Brescia propose a multicenter study, based in Italy, to optimize scientific knowledge in the field of studies of the effects of the COVID-19 pandemic on the perinatal period. There is a paucity of studies evaluating the psychological impact of the COVID-19 pandemic on couples experiencing the loss of their child in the perinatal period.

The main aims of this study are as follows:

This longitudinal observational multicenter study is structured according to a mixed methods design, with a quantitative and qualitative part. The timeline of the whole procedure is shown in Figure 1. The study comprises two phases, which are a baseline (Figure 1: T1) and a 6-month follow-up (Figure 1: T2).

Health care professionals (psychologists, psychotherapists, psychiatrists, midwives, etc) will conduct the study at health care centers throughout Italy (counseling centers, hospitals, etc) and the facilities involved and coordinated by the Observatory of Perinatal Clinical Psychology of the University of Brescia (Table 1). Among the mothers and fathers attending the health care centers, health care professionals will identify those who have experienced perinatal loss since the beginning of the COVID-19 pandemic (from March 2020) and will inform them about the study (Figure 1: T0). Health care professionals will provide mothers and fathers with an information note describing the aims of the study and will ask them to sign a declaration of informed consent if they intend to participate in the study. The first data collection time point (Figure 1: T1) will be after the death of the child, as soon as the parental couples are available to participate in the study, considering the difficulties due to the trauma for their perinatal loss. To protect their privacy, parents who agree to participate will be assigned a code with which they will become part of the study (participants can authorize the communication of their name to the research centers). Health care professionals will communicate the code or name of individuals participating to the Observatory of Perinatal Clinical Psychology of the University of Brescia. Both health care professionals and recruited participants will take part in this study voluntarily and without compensation.

Mothers and fathers who experienced perinatal loss during the COVID-19 pandemic form March 2020 and who are proficient in Italian are included in the study.

The main exclusion criterion is mental health—participants must not be diagnosed with a mental disorder by a psychiatrist and must not be undergoing psychiatric or psychopharmacological treatment.

In this Study, the participants (mothers and fathers) will be invited to participate in two phases of data collection. In the first phase (Figure 1: baseline—T1) they will perform the following:

In the second phase of data collection (Figure 1: follow-up—T2, after 6 months), mothers and fathers will be asked to complete the questionnaire and the interview by health care professionals. All data collected at each step will be deidentified and stored in a secure, password-protected drive with access only available to the research team members.

The primary outcome for this study is the impact of the COVID-19 pandemic on the grief of mothers and fathers who experienced a perinatal loss during the pandemic. The secondary outcomes are the changes in social and couple relationships, maternal or paternal affectivity and satisfaction, spirituality, trauma, grieving strategies, and unhelpful or helpful factors. The tertiary outcomes relate to understanding the type of responsibility that parents ascribe to COVID-19 with respect to their perinatal loss.

The primary endpoint of this study is the impact of the COVID-19 pandemic on the grief of mothers and fathers who experienced a perinatal loss during the pandemic. Considering a power (1-β) of 0.80 and a type I error (α) of .05, a sample of 34 parental couples is needed. The sample size is extremely low, but it will be in line with literature studies on perinatal loss that include and analyze small samples of couples [92,93]. As indicated by literature [94], the mixed methods design can help studies that involve small samples.

Quantitative and qualitative analysis will be carried out for the questionnaires and interviews. Appropriate data analysis will be performed using standard statistical packages.

Our study protocol was reviewed and approved by the Ethics Committee of Psychological Research, University of Padova (N. 3989 - 09/02/2021), and by the Institutional Ethics Board of the Spedali Civili of Brescia, Italy (N. NP4858 - 07/10/2021). All procedures performed in this study are in accordance with the ethical standards of the Institutional Ethics Board of the Spedali Civili of Brescia, and with the Declaration of Helsinki 1964 and subsequent amendments. We shall obtain written consent from the parents.

The parents were not involved in the design, conduct, reporting, or dissemination plans of this research.

Personal information about potential and enrolled participants will be collected only by members of the research team and cannot be accessed by other individuals. Personal information and survey data will be pseudonymized using an identification number. Only authorized study personnel will have access to any of the data associated with this study.

The COVID-19 pandemic forced health services to redefine perinatal bereavement care protocols [78,79] due to the restrictions imposed to curb the spread of the virus. However, health care professionals were unprepared for these changes [31,32], which led to an increase in perinatal affective disorders in mothers and fathers [70], who felt isolated and lacking social support [36,37] at such a challenging time. To our knowledge, the impact of COVID-19 on care following the death of a baby has not been sufficiently explored.

This multicenter study will contribute to optimize the scientific knowledge in the field of studies of the impact of the COVID-19 pandemic on pregnancy and particularly on mothers and fathers grieving for a perinatal loss. It will contribute to the understanding of the psychological processes related to perinatal loss, bereavement care, and mourning during the COVID-19 pandemic; it will also provide information useful to preventing the risk of prolonged and complicated grief and parent psychopathologies and will promote perinatal mental health.

Regarding the implications in clinical practice, it would seem important to implement psychological services in health care centers (eg, counseling centers and obstetrics and gynecology wards) that can offer adequate support to mothers, fathers, and families who are experiencing the unexpected and painful event of perinatal loss of their child, especially if this happens in difficult and complex situations such as a global health emergency.

This study could pave the way for future scientific research in the same or similar area of interest that should consider perinatal bereavement, an event still poorly investigated and not always socially recognized, to develop a strong support system for the affected mothers, fathers, and families.

The most likely limitation of this study could be that some parents contacted by health care professionals may not agree to participate because the perinatal loss event may have been too traumatic and painful, and they may not want to talk about it anymore after it happened. Concerning data collection time point, recruited parental couples may not have experienced perinatal loss in the same week of pregnancy or in the same neonatal period, and this could be another limitation of this study. What the sample couples share is that the perinatal loss event occurred during the COVID-19 pandemic. Lastly, the sample, composed only of parents who speak and understand the Italian language, may be too small to be able to generalize the results.