1. Invasive therapies for primary postpartum haemorrhage: a population-based study in France Gilles Kayem, MD PhD, Corinne Dupont RM PhD, MH Bouvier-Colle PhD, RC Rudigoz MD, Catherine Deneux-Tharaux, MD PhD.

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3. Scenario During a multidisciplinary training day on the management of post-partum haemorrhage (PPH), a number of invasive therapies were described. One of the delegates asked, “how often are these invasive therapies used? Are they effective?”

4. The Clinical Question What are the characteristics of women with primary postpartum haemorrhage (PPH) in France and their clinical outcomes? What are the incidence and type of invasive therapies used for PPH?

5. Structured question (PICOD) ParticipantsWomen who have participated in the PITHAGORE6 trial (106 maternity units in 6 French regions) and developed primary PPH between December 2004 and November 2006 InterventionInvasive therapies for PPH, including uterine suture, pelvic vessel ligation, arterial embolisation and hysterectomy. ComparisonNational databases in the UK and Netherlands OutcomesMaternal mortality, hysterectomy rate, incidence of conservative invasive therapies and their failure rates Study DesignObservational study (retrospective analysis of a large clinical trial cohort)

6. Background Conservative invasive therapies for PPH are increasingly used to manage post-partum haemorrhage Variations in the management of PPH in different countries may have impact on maternal mortality and morbidities Population-based data is lacking in countries without prospective surveillance programme for less common complications of pregnancy, including severe PPH

7. Background In your local practice, how often are invasive therapies used to manage PPH? Moreover, which type of invasive therapies is the most frequently used?

8. Women delivered during the study period, N=146 781 Women with clinically diagnosed PPH, n=6600 Women treated by invasive therapies, n=296 Conservative therapies n=262 Hysterectomy n=72 Analyses performed in this study: – By mode of delivery – By the type of invasive therapies used – Comparison with population-based data in the UK and Netherlands Methods

9. What are the advantages and disadvantages of a retrospective analysis of large clinical trial datasets compared to a prospective population-based surveillance programme? How may a prospective population-based surveillance programme further improve the quality of the data collected in this study?

10. Incidence of invasive therapies for postpartum haemorrhage (PPH) by route of delivery

11. Need for additional procedure: overall, by initial invasive procedure used and by route of delivery

12. Comparison of selected maternal outcomes in France, UK and Netherlands, based on the most recent available data

13. 262/6600 women (4%) had first-line conservative invasive therapies: – 183 (70%) had uterine arterial embolization (UAE) – 79 (30%) had conservative surgery UAE was more frequently used for PPH after vaginal delivery and when UAE was available on site. The overall failure rate of conservative invasive therapies was 41/262 (15.6% [95% CI 11.5–20.6]) Compared to UAE, conservative surgical therapies were associated with a higher failure rate, in particular for PPH after vaginal deliveries. Results

14. How do maternal mortality and morbidity rates from PPH in France compare to those in the UK and Netherlands (see Table 4)? Which factors may have caused the observed differences in maternal mortality and morbidities? Results

15. Both maternal mortality due to obstetric haemorrhage and rate of invasive therapies for PPH were high in France. These findings suggest possible flaws in the initial management of PPH, and/or inadequate use of invasive procedures. Authors’ conclusion

16. Did the results of the current study support the authors’ conclusions? How would the results of this study influence your daily practice? Discussion

17. Suggested reading Deneux-Tharaux C, Dupont C, Colin C, Rabilloud M, Touzet S, Lansac J, Harvey T, Tessier V, Chauleur C, Pennehouat G, Morin X, Bouvier-Colle M, Rudigoz R. Multifaceted intervention to decrease the rate of severe postpartum haemorrhage: the PITHAGORE6 cluster-randomised controlled trial. BJOG 2010;117:1278–1287. Kassebaum NJ, Bertozzi-Villa A, Coggeshall MS, Shackelford KA, Steiner C, Heuton KR, Gonzalez-Medina D, Barber R, et al. Global, regional, and national levels and causes of maternal mortality during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Sep 13;384(9947):980-1004. Doumouchtsis SK, Nikolopoulos K, Talaulikar V, Krishna A, Arulkumaran S. Menstrual and fertility outcomes following the surgical management of postpartum haemorrhage: a systematic review. BJOG. 2014 Mar;121(4):382-8.

18. Authors’ Affiliations Gilles Kayem 1,2, MD PhD, Corinne Dupont 3 RM PhD, MH Bouvier-Colle 1 PhD, RC Rudigoz 3 MD, Catherine Deneux- Tharaux 1, MD PhD. 1.Inserm UMR 1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team (EPOPé), Center for Epidemiology and Statistics Sorbonne Paris Cité, DHU Risks in pregnancy, Paris Descartes University, Paris France 2. Department of Obstetrics and Gynecology, Trousseau Hospital, APHP, Université Pierre et Marie Curie, Paris 3. Aurore perinatal network, Hôpital de la Croix Rousse, Hospices Civils de Lyon, EA 4129 Université Lyon1, Lyon France Authors have no conflict of interest