Uptake and Adherence to National Guidelines on Postpartum Haemorrhage in Italy: The MOVIE before–after Observational Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Before–after Observational Study
- A clinical pathway on the prevention, diagnosis, and management of PPH developed in accordance with the selected recommendations from the national guidelines;
- A poster describing the flow chart for PPH management reviewed by experienced obstetricians, anaesthesiologists, and midwifes, recognised at the national level;
- A modified early obstetrics warning system (MEOWS) monitoring and alert chart adapted for the national context;
- A situation background assessment recommendation (SBAR) methodology [21] proposed as a technique to facilitate communication between professionals in the event of a PPH emergency.
2.2. Cross-Sectional Study
3. Results
3.1. Online Survey for the Chief Physicians
3.2. Before–after Checklists for the MUs Contact Clinicians
3.3. Data Analysis of the PPH Cases Notified during the Study Period
3.4. PPH Prevention
3.5. PPH Medical and Surgical Treatment
3.6. Fluid and Transfusion Management
3.7. Maternal and Perinatal Outcomes
3.8. Risk Management
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A. The ItOSS MOVIE Working Group
References
- Say, L.; Chou, D.; Gemmill, A.; Tunçalp, Ö.; Moller, A.B.; Daniels, J.; Gülmezoglu, A.M.; Temmerman, M.; Alkema, L. Global causes of maternal death: A WHO systematic analysis. Lancet Glob. Health 2014, 2, e323–e333. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- EURO-PERISTAT Project with SCPE and EUROCAT. European Perinatal Health Report. Health and Care of Pregnant Women and Babies in Europe in 2010. May 2013. Available online: https://www.europeristat.com/images/European%20Perinatal%20Health%20Report_2010.pdf (accessed on 15 February 2023).
- Koch, A.R.; Roesch, P.T.; Garland, C.E.; Geller, S.E. Implementing Statewide Severe Maternal Morbidity Review: The Illinois Experience. J. Public Health Manag. Pract. 2018, 24, 458–464. [Google Scholar] [CrossRef] [PubMed]
- Les Morts Maternelles en France: Mieux Comprendre Pour Mieux Prévenir [Internet]. 6ème Rapport de l’Enquête Nationale Confidentielle sur les Morts Maternelles (ENCMM), 2013–2015; Santé Publique France: Saint-Maurice, France, 2021; Available online: https://www.santepubliquefrance.fr/maladies-et-traumatismes/maladies-cardiovasculaires-et-accident-vasculaire-cerebral/maladies-vasculaires-de-la-grossesse/documents/enquetes-etudes/les-morts-maternelles-en-france-mieux-comprendre-pour-mieux-prevenir.-6e-rapport-de-l-enquete-nationale-confidentielle-sur-les-morts-maternelles (accessed on 15 February 2023).
- Escobar, M.F.; Nassar, A.H.; Theron, G.; Barnea, E.R.; Nicholson, W.; Ramasauskaite, D.; Lloyd, I.; Chandraharan, E.; Miller, S.; Burke, T.; et al. FIGO recommendations on the management of postpartum hemorrhage 2022. Int J. Gynaecol. Obstet. 2022, 157, 3–50. [Google Scholar] [CrossRef] [PubMed]
- Mavrides, E.; Allard, S.; Chandraharan, E.; Collins, P.; Green, L.; Hunt, B.J.; Riris, S.; Thomson, A.J.; on behalf of the Royal College of Obstetricians and Gynaecologists. Prevention and management of postpartum haemorrhage. BJOG 2016, 124, e106–e149. [Google Scholar] [CrossRef]
- Donati, S.; Senatore, S.; Ronconi, A.; Regional maternal mortality working group. Maternal Mortality in Italy: A record linkage study. BJOG 2011, 118, 872–879. [Google Scholar] [CrossRef] [Green Version]
- Bowyer, L. The Confidential Enquiry into Maternal and Child Health (CEMACH). Saving Mothers’ Lives: Reviewing maternal deaths to make motherhood safer 2003–2005. The Seventh Report of the Confidential Enquiries into Maternal Deaths in the UK. Obstet. Med. 2008, 1, 54. [Google Scholar] [CrossRef]
- Donati, S.; Buoncristiano, M.; Lega, I.; D’Aloja, P.; Maraschini, A.; ItOSS working group. The Italian Obstetric Surveillance System: Implementation of a bundle of population-based initiatives to reduce haemorrhagic maternal deaths. PLoS ONE 2021, 16, e0250373. [Google Scholar] [CrossRef]
- Maraschini, A.; Lega, I.; D’Aloja, P.; Buoncristiano, M.; Dell’Oro, S.; Donati, S.; Regional Obstetric Surveillance System Working Group. Women undergoing peripartum hysterectomy due to obstetric hemorrhage: A prospective population-based study. Acta Obstet. Gynecol. Scand. 2020, 99, 274–282. [Google Scholar] [CrossRef]
- Ornaghi, S.; Maraschini, A.; Donati, S.; Regional Obstetric Surveillance System Working Group. Characteristics and outcomes of pregnant women with placenta accreta spectrum in Italy: A prospective population-based cohort study. PLoS ONE 2021, 16, e0252654. [Google Scholar] [CrossRef]
- Donati, S.; Fano, V.; Maraschini, A.; Regional Obstetric Surveillance System Working Group. Uterine rupture: Results from a prospective population-based study in Italy. Eur. J. Obstet. Gynecol. Reprod. Biol. 2021, 264, 70–75. [Google Scholar] [CrossRef]
- D’Aloja, P.; Maraschini, A.; Lega, I.; Andreozzi, S.; Sampaolo, L.; Valetto, M.R.; Dri, P.; Donati, S.M. Acceptance of e-Learning Programs for Maternity Health Care Professionals Implemented by the Italian Obstetric Surveillance System. J. Contin. Educ. Health Prof. 2020, 40, 289–292. [Google Scholar] [CrossRef] [PubMed]
- Sistema Nazionale Linee Guida. Emorragia Post Partum: Come Prevenirla, Come Curarla. Available online: https://www.epicentro.iss.it/itoss/pdf/SNLG_EPP-2016web_corrige.pdf (accessed on 15 February 2023). (In Italian).
- Resar, R.; Griffin, F.A.; Haraden, C.; Nolan, T.W. Using Care Bundles to Improve Health Care Quality; IHI Innovation Series White Paper; Institute for Healthcare Improvement: Cambridge, MA, USA, 2012; Available online: https://www.ihi.org/resources/Pages/IHIWhitePapers/UsingCareBundles.aspx (accessed on 15 February 2023).
- The National Institute for Health and Care Excellence. Practical Steps to Improving the Quality of Care and Services Using NICE Guidance. Available online: https://www.nlm.nih.gov/bsd/uniform_requirements.html#journals (accessed on 15 February 2023).
- Wang, Z.; Norris, S.L.; Bero, L. Implementation plans included in World Health Organisation guidelines. Implement. Sci. 2016, 11, 76. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- de Visser, S.M.; Woiski, M.D.; Grol, R.P.; Vandenbussche, F.P.H.A.; Hulscher, M.E.J.L.; Scheepers, H.C.J.; Hermens, R.P.M.G. Development of a tailored strategy to improve postpartum hemorrhage guideline adherence. BMC Pregnancy Childbirth 2018, 18, 49. [Google Scholar] [CrossRef] [Green Version]
- Nadisauskiene, R.J.; Kliucinskas, M.; Dobozinskas, P.; Kacerauskiene, J. The impact of postpartum hemorrhage management guidelines implemented in clinical practice: A systematic review of the literature. Eur. J. Obstet. Gynecol. Reprod. Biol. 2014, 178, 21–26. [Google Scholar] [CrossRef]
- Sistema Nazionale Linee Guida. Emorragia Post Partum: Come Prevenirla, Come Curarla. Available online: https://www.epicentro.iss.it/itoss/pdf/LGEPPdivulg.pdf (accessed on 15 February 2023). (In Italian).
- Shahid, S.; Thomas, S. Situation, Background, Assessment, Recommendation (SBAR) Communication Tool for Handoff in Health Care—A Narrative Review. Saf. Health 2018, 4, 7. [Google Scholar] [CrossRef] [Green Version]
- Accordo ai Sensi Dell’art. 4 del Decreto Legislativo 28 Agosto 1997, n. 281, tra il Governo, le Regioni e le Province Autonome di Trento e Bolzano sul Documento Recante “Linee di Indirizzo per la Promozione ed il Miglioramento della Qualità, della Sicurezza e Dell’appropriatezza Degli Interventi Assistenziali nel Percorso Nascita e per la Riduzione del Taglio Cesareo”. Available online: https://oporp.it/custom/oporp/writable/news/ACCORDO-STATO-REGIONI1.pdf (accessed on 15 February 2023). (In Italian).
- Direzione Generale della Digitalizzazione, del Sistema Informativo Sanitario e della Statistica Ufficio di Statistica. Certificato di Assistenza al Parto (CeDAP) Analisi Dell’evento Nascita—Anno 2019. Available online: https://www.salute.gov.it/imgs/C_17_pubblicazioni_3076_allegato.pdf (accessed on 15 February 2023). (In Italian)
- Bell, S.F.; Collis, R.E.; Pallmann, P.; Bailey, C.; James, K.; John, M.; Kelly, K.; Kitchen, T.; Scarr, C.; Watkins, A.; et al. Reduction in massive postpartum hemorrhage and red blood cell transfusion during a national quality improvement project, Obstetric Bleeding Strategy for Wales, OBS Cymru: An observational study. BMC Pregnancy Childbirth 2021, 21, 377. [Google Scholar] [CrossRef] [PubMed]
- Vendittelli, F.; Barasinski, C.; Rivière, O.; Da Costa Correia, C.; Crenn-Hébert, C.; Dreyfus, M.; Legrand, A.; Gerbaud, L. Does the Quality of Postpartum Hemorrhage Local Protocols Improve the Identification and Management of Blood Loss after Vaginal Deliveries? A Multicenter Cohort Study. Healthcare 2022, 10, 992. [Google Scholar] [CrossRef] [PubMed]
- Duzyj, C.M.; Boyle, C.; Mahoney, K.; Johnson, A.R.; Ogot, G.; Ayers, C. The Postpartum Hemorrhage Patient Safety Bundle Implementation at a Single Institution: Successes, Failures, and Lessons Learned. Am. J. Perinatol. 2021, 38, 1281–1288. [Google Scholar] [CrossRef]
- Joseph, N.T.; Worrell, N.H.; Collins, J.; Schmidt, M.; Sobers, G.; Hutchins, K.; Chahine, E.B.; Faya, C.; Lewis, L.; Green, V.L.; et al. Implementation of a Postpartum Hemorrhage Safety Bundle at an Urban Safety-Net Hospital. Am. J. Perinatol. Rep. 2020, 10, e255–e261. [Google Scholar] [CrossRef]
- Regione Emilia-Romagna Atti Amministrativi Giunta Regionale “Linee di Programmazione e di Finanziamento delle Aziende e Degli Enti del Servizio Sanitario Regionale per L’anno 2018. Delibera n. 919 (18 June 2018). Available online: https://bur.regione.emilia-romagna.it/dettaglio-inserzione?i=2af3f298e47646a697b52e81eb9c90e2 (accessed on 15 February 2023). (In Italian).
- Kallianidis, A.F.; Maraschini, A.; Danis, J.; Colmorn, L.B.; Deneux-Tharaux, C.; Donati, S.; Gissler, M.; Jakobsson, M.; Knight, M.; Kristufkova, A.; et al. Epidemiological analysis of peripartum hysterectomy across nine European countries. Acta Obstet. Gynecol. Scand. 2020, 99, 1364–1373. [Google Scholar] [CrossRef]
- Donati, S.; Maraschini, A.; Lega, I.; D’Aloja, P.; Buoncristiano, M.; Manno, V. Maternal mortality in Italy: Results and perspectives of record-linkage analysis. Acta Obstet. Gynecol. Scand. 2018, 97, 1317–1324. [Google Scholar] [CrossRef] [PubMed]
Checklist Item | Before the Start of the Project N = 24 | At the End of the Project N = 24 | ||
---|---|---|---|---|
Yes n (%) | No n (%) | Yes n (%) | No n (%) | |
Checklist of risk factors for PPH identification and documentation included in the medical record | 8 (33%) | 16 (67%) | 13 (54%) | 11 (46%) |
Use of recommended methods for quantifying blood loss (graduated bags, counting of gauze and drapes, etc.) | 24 (100%) | 0 | 24 (100%) | 0 |
Use of graphic charts for monitoring/alerting vital signs (e.g., MEOWS) | 14 (58%) | 10 (42%) | 22 (92%) | 2 (8%) |
Early administration of 1 g of tranexamic acid in addition to the standard therapy with uterotonics in case of PPH | 13 (54%) | 11 (46%) | 22 (92%) | 2 (8%) |
Availability of intrauterine balloons for the treatment of PPH in the delivery room | 23 (96%) | 1 (4%) | 24 (100%) | 0 |
Periodic training sessions in the use of the intrauterine balloon | 12 (50%) | 12 (50%) | 16 (67%) | 8 (33%) |
Availability of a procedure with working instructions shared with the blood transfusion centre on how to request and obtain emergency blood, including group 0 blood, Rh D and K negative, in case of PPH | 23 (96%) | 1 (4%) | 24 (100%) | 0 |
Availability of a shared procedure between gynaecologists, anaesthesiologists, obstetricians, and transfusionists for the clinical management of women who refuse transfusion | 6 (25%) | 18 (75%) | 8 (33%) | 16 (67%) |
Availability of a clinical pathway for the prevention and treatment of PPH | 20 (83%) | 4 (17%) | 23 (96%) | 1 (4%) |
Availability of a shared procedure between gynaecologists, anaesthesiologists, midwives, and transfusionists for the management of women at increased risk of PPH | 19 (79%) | 5 (21%) | 22 (92%) | 2 (8%) |
Availability of a visible poster with an operational flow-chart on the management of PPH In the delivery room | 13 (54%) | 11 (46%) | 23 (96%) | 1 (4%) |
Availability of a kit (drugs, devices, etc.) dedicated to bleeding emergencies in the delivery room | 19 (79%) | 5 (21%) | 24 (100%) | 0 |
Organisation of multi-professional training on the management of obstetric emergencies, including PPH, involving gynaecologists, anaesthesiologists, midwives, and nurses simultaneously | 19 (79%) | 5 (21%) | 22 (92%) | 2 (8%) |
Periodic multi-professional simulations of PPH treatment in place (missing = 2) | 10 (42%) | 12 (50%) | 14 (58%) | 8 (33%) |
Adoption of a structured way to manage communication with family members in the event of a haemorrhagic emergency | 5 (21%) | 19 (79%) | 11 (46%) | 13 (54%) |
Routinely offer to the woman and partner of a counselling on the events characterizing the bleeding, including the risk for future pregnancies before discharge (missing = 7) | 5 (21%) | 12 (50%) | 10 (42%) | 7 (29%) |
Periodic clinical audits to assess cases of severe PPH (>1500 mL) (missing = 2) | 7 (29%) | 15 (63%) | 15 (63%) | 7 (29%) |
Variable | N = 1100 | |
---|---|---|
n | % | |
Age in years | ||
<35 | 591 | 53.8 |
35–39 | 370 | 33.6 |
≥40 | 139 | 12.6 |
Pre-pregnancy BMI | ||
<18.5 | 68 | 6.6 |
18.5–24.9 | 634 | 61.6 |
25.0–29.9 | 221 | 21.5 |
≥30 | 106 | 10.3 |
Missing | 71 | 6.5 |
Citizenship | ||
Not Italian | 215 | 21.1 |
Italian | 803 | 78.9 |
Missing | 82 | 7.5 |
Educational level | ||
<18.5 | 10 | 1.1 |
18.5–24.9 | 209 | 22.0 |
25.0–29.9 | 368 | 38.6 |
≥30 | 365 | 38.3 |
Missing | 148 | 13.5 |
Parity | ||
Primipara | 464 | 43.0 |
Multipara | 615 | 57.0 |
Missing | 21 | 1.9 |
Multiple pregnancy | 77 | 7.0 |
Hysterotomy | 213 | 19.4 |
Previous CS | 160 | 14.6 |
Previous hysterotomy | 109 | 9.9 |
Induction of labour | 325 | 29.5 |
Oxytocin augmentation | 314 | 28.5 |
Pharmacological analgesia | 343 | 31.2 |
Mode of birth | ||
Vaginal birth | 597 | 54.3 |
Instrumental vaginal birth | 68 | 6.2 |
Elective CS | 213 | 19.4 |
Urgent CS | 186 | 16.9 |
Emergency CS | 36 | 3.3 |
Variable | Total (N = 1100) | 1000–1500 mL (n = 833) | 1501–2000 mL (n = 186) | >2000 mL (n = 81) | |||||
---|---|---|---|---|---|---|---|---|---|
n | % | n | % | n | % | n | % | ||
Use of graphic charts for monitoring vital signs postpartum | Yes | 417 | 38.8 | 297 | 36.6 | 84 | 45.9 | 36 | 45.0 |
No | 657 | 61.2 | 514 | 63.4 | 99 | 54.1 | 44 | 55.0 | |
Missing | 26 | 2.4 | 22 | 2.6 | 3 | 1.6 | 1 | 0.0 | |
Use of at least a recommended method for blood loss estimate | Yes | 1082 | 98.8 | 824 | 99.2 | 179 | 97.8 | 79 | 97.5 |
No | 13 | 1.2 | 7 | 0.8 | 4 | 2.2 | 2 | 2.5 | |
Missing | 5 | 0.5 | 2 | 0.2 | 3 | 1.6 | - | - | |
Availability of PT ratio during bleeding | Yes | 557 | 50.9 | 388 | 46.7 | 119 | 64.3 | 50 | 63.3 |
No | 537 | 49.1 | 442 | 53.3 | 66 | 35.7 | 29 | 36.7 | |
Missing | 6 | 0.5 | 3 | 0.4 | 1 | 0.5 | 2 | 2.5 | |
Availability of APTT ratio during bleeding | Yes | 622 | 57.0 | 433 | 52.4 | 128 | 69.2 | 61 | 77.2 |
No | 468 | 43.0 | 393 | 47.6 | 57 | 30.8 | 18 | 22.8 | |
Missing | 10 | 0.9 | 7 | 0.8 | 1 | 0.5 | 2 | 2.5 | |
Tranexamic acid | Yes | 635 | 57.8 | 438 | 52.6 | 130 | 69.9 | 67 | 82.7 |
No | 463 | 42.1 | 393 | 47.2 | 56 | 30.1 | 14 | 17.3 | |
Missing | 2 | 0.2 | 2 | 0.2 | - | - | - | - | |
Prostaglandins | Yes | 778 | 70.9 | 645 | 77.6 | 97 | 52.2 | 36 | 44.4 |
No | 320 | 29.1 | 186 | 22.4 | 89 | 47.8 | 45 | 55.6 | |
Missing | 2 | 0.2 | 2 | 0.2 | - | - | - | - | |
Balloon tamponade | Yes | 165 | 15.6 | 83 | 10.4 | 49 | 27.2 | 33 | 43.4 |
No | 892 | 84.4 | 718 | 89.6 | 131 | 72.8 | 43 | 56.6 | |
Missing | 43 | 3.9 | 32 | 3.8 | 6 | 3.2 | 5 | 6.2 | |
Surgical procedures and/or artery embolisation | Yes | 104 | 9.5 | 50 | 6.2 | 23 | 12.7 | 31 | 39.2 |
No | 957 | 87.0 | 751 | 93.8 | 158 | 87.3 | 48 | 60.8 | |
Missing | 39 | 3.5 | 32 | 3.8 | 5 | 2.7 | 2 | 2.5 | |
Transfusion of packed red blood cells | Yes | 246 | 22.5 | 100 | 12.1 | 78 | 41.9 | 68 | 85.0 |
No | 848 | 77.5 | 728 | 87.9 | 108 | 58.1 | 12 | 15.0 | |
Missing | 6 | 0.5 | 5 | 0.6 | - | - | 1 | 0.0 |
Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content. |
© 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
Share and Cite
Donati, S.; Buoncristiano, M.; D’Aloja, P.; Maraschini, A.; Corsi Decenti, E.; Lega, I.; The ItOSS MOVIE Working Group. Uptake and Adherence to National Guidelines on Postpartum Haemorrhage in Italy: The MOVIE before–after Observational Study. Int. J. Environ. Res. Public Health 2023, 20, 5297. https://doi.org/10.3390/ijerph20075297
Donati S, Buoncristiano M, D’Aloja P, Maraschini A, Corsi Decenti E, Lega I, The ItOSS MOVIE Working Group. Uptake and Adherence to National Guidelines on Postpartum Haemorrhage in Italy: The MOVIE before–after Observational Study. International Journal of Environmental Research and Public Health. 2023; 20(7):5297. https://doi.org/10.3390/ijerph20075297
Chicago/Turabian StyleDonati, Serena, Marta Buoncristiano, Paola D’Aloja, Alice Maraschini, Edoardo Corsi Decenti, Ilaria Lega, and The ItOSS MOVIE Working Group. 2023. "Uptake and Adherence to National Guidelines on Postpartum Haemorrhage in Italy: The MOVIE before–after Observational Study" International Journal of Environmental Research and Public Health 20, no. 7: 5297. https://doi.org/10.3390/ijerph20075297