OC 02.2 - PRegnancy and Inherited bleeding DisordErs Study: interim safety analysis after revision of the Dutch guideline.

Saturday, June 24, 2023

13:15 – 13:30 ET

Room: 710A

Session Available As: Live-Stream and On-Demand

Presenting Author(s)

Anne de Vaan, MD (she/her/hers)

PhD student
Center of Benign Haematology, Thrombosis and Haemostasis, van Creveldkliniek, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
Utrecht, Utrecht, Netherlands

Co-Author(s)

MK

Marieke J.H.A. Kruip

Associate professor, hematologist, MD, PhD
Department of Hematology, Erasmus MC, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands
Rotterdam, Zuid-Holland, Netherlands
Jeroen C.J Eikenboom, MD. PhD

Professor, Head of Division of Thrombosis and Hemostasis
Leiden University Medical Center
Leiden, Zuid-Holland, Netherlands
MP

Marieke Punt

PhD, MD
Center of Benign Haematology, Thrombosis and Haemostasis, van Creveldkliniek, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
Zeist, Utrecht, Netherlands
SS

Saskia E.M. Schols

Internist-hematologist
Department of Hematology, Radboud university medical center, Nijmegen, The Netherlands. Hemophilia Treatment Center Nijmegen – Eindhoven – Maastricht, The Netherlands
Nijmegen, Gelderland, Netherlands
FH

Floor C.J.I. Heubel-Moenen

Hematologist
Department Hematology, MUMC+, Maastricht, the Netherlands
Maastricht, Limburg, Netherlands
Michiel Coppens, MD, PhD (he/him/his)

Medical Specialist
Amsterdam University Medical Centers, Amsterdam, The Netherlands
Amsterdam, Noord-Holland, Netherlands
LN

Laurens Nieuwenhuizen

Internist-hematologist
Hemophilia Treatment Center Nijmegen – Eindhoven – Maastricht, The Netherlands. Department of Hematology, Maxima Medical Center, Eindhoven, The Netherlands.
Eindhoven, Noord-Brabant, Netherlands
AM

Anja Makelburg

Internist-Hematologist
Department of Hematology, University Medical Center Groningen, Groningen, the Netherlands.
Groningen, Groningen, Netherlands
MP

Marjolein Peters

Pediatric hematologist
Department of Pediatric Hematology, Amsterdam University Medical Centers, location Emma Children’s Hospital, Amsterdam, The Netherlands
Amsterdam, Noord-Holland, Netherlands
HD

Hans Duvekot

Gynaecologist, Maternal Fetal Medicine Specialist
Department of Gynaecology and Obstetrics, Erasmus MC, Erasmus University Medical Center, Rotterdam, the Netherlands
Rotterdam, Zuid-Holland, Netherlands
AM

Annemieke Middeldorp

Gynaecologist, Maternal Fetal Medicine Specialist
Department of Obstetrics, Leiden University Medical Center, Leiden, the Netherlands
Leiden, Zuid-Holland, Netherlands
KB

Kitty Bloemenkamp

Gynaecologist, Professor in Obstetrics
Department of Obstetrics, Wilhelmina Children's Hospital Birth Center, University Medical Center Utrecht, Utrecht, the Netherlands
Utrecht, Utrecht, Netherlands
Roger E.G Schutgens, MD, PhD, MSc (he/him/his)

Internist-hematologist, Professor
Center for Benign Hematology, Thrombosis and Hemostasis, Van Creveldkliniek, University Medical Center Utrecht and University Utrecht, Utrecht, The Netherlands
Utrecht, Utrecht, Netherlands
TL

Titia Lely

Gynaecologist, Associate Professor
Department of Obstetrics, Wilhelmina Children's Hospital Birth Center, University Medical Center Utrecht, Utrecht, the Netherlands
Utrecht, Utrecht, Netherlands
Karin P. M. van Galen, MD PhD MsC

Internist Hematologist
Center for Benign Haematology, Thrombosis and Haemostasis, Van Creveldkliniek, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
Utrecht, Utrecht, Netherlands

Background: Due to high incidence of postpartum hemorrhage (PPH, ≥500 ml) and severe PPH (≥1000 ml) in women with von Willebrand disease (VWD) or hemophilia carriers (HC) (34% and 10%, respectively) the Dutch guideline concerning pregnant women with inherited bleeding disorders has been revised. Since 2018, pregnant women with VWD and HC receive prophylactic clotting factors (CF) if third trimester CF levels are < 80 IU/dL instead of < 50 IU/dL. Target peak CF levels at delivery were raised from 100 IU/dL to 150 IU/dL. The primary aim of the PRIDES is to assess the incidence of severe PPH after guideline revision.

Aims: Interim analysis on included patients. Safety analysis of the first 24 inclusions in the ≤50 IU/dL group. If ≥9 cases of severe PPH occur in this group, premature guideline re-revision will be mandatory.

Methods: Ongoing multicenter cohort study. Pregnant women with VWD or HC were treated by the revised guideline with care coordinated by hemophilia treatment centers in the Netherlands.

Results: Since 2018, 137 pregnancies (70 VWD, 77 HCs) were included. Mean age was 33.8 years (SD 4.1) History of PPH was reported in 22% (n=30/137). In the < 80 IU/dL group, 90% (n=43/48) received prophylactic CF. In the ≥80 IU/dL group, 7% (n=6/89) received on demand CF treatment. Severe PPH occurred in 25% (n=12/48) of the group < 80 IU/dL. The incidence of severe PPH in the women ≤50 IU/dL was 25% (n=6/24).

Conclusion(s): This interim analysis shows a persistent high incidence of severe PPH of 25% in the group with third trimester CF levels ≤50 IU/dL despite augmented prophylactic CF treatment. Safety analysis does not dictate premature guideline revision. Final results of the PRIDES are expected within 2-3 years.

Learning Objectives:

Upon completion, participants will be able to summarize the current Dutch guideline concering postpartum hemorrhage management in pregnant women with an inherited bleeding disorder.
Upon completion, participants will be able to identify the potential implications of earlier prophylactic clotting factor treatment on maternal outcomes in pregnant women with an inherited bleeding disorder.
Upon completion, participants will be able to understand the impact of prophylactic clotting factor treatment on the incidence of postpartum hemorrhage in pregnant women with an inherited bleeding disorder.