Evidence map›Paper›PMID 42254459›Full record

ArticleResearch and practice in thrombosis and haemostasis2026

Menstrual outcomes are frequently overlooked in von Willebrand disease trials.

Meaghan O'Donnell, Claire Kelly, Rezan Abdul Kadir, Roseline D'Oiron, Petra Elfvinge, Gaby Golan, Keith Gomez, Samantha C Gouw, Laura Quintas, Karin P M van Galen and 1 more

Abstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

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0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

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5 · Who and what money

Authors and funding

11 authors.

Meaghan O'DonnellIrish Centre for Vascular Biology, School of Pharmacy & Biomedical Sciences, RCSI, Dublin, Ireland.
Claire KellyIrish Centre for Vascular Biology, School of Pharmacy & Biomedical Sciences, RCSI, Dublin, Ireland.
Rezan Abdul KadirKatharine Dormandy Haemophilia and Thrombosis Unit, Department of Obstetrics and Gynaecology, Royal Free Foundation Hospital and Institute for Women's Health, University College London, London, UK.
Roseline D'OironWomen & Girls with Bleeding Disorders + Working Group, European Association for Haemophilia and Allied Disorders, Brussels, Belgium.
Petra ElfvingeWomen & Girls with Bleeding Disorders + Working Group, European Association for Haemophilia and Allied Disorders, Brussels, Belgium.
Gaby GolanWomen & Girls with Bleeding Disorders + Working Group, European Association for Haemophilia and Allied Disorders, Brussels, Belgium.
Keith GomezWomen & Girls with Bleeding Disorders + Working Group, European Association for Haemophilia and Allied Disorders, Brussels, Belgium.
Samantha C GouwWomen & Girls with Bleeding Disorders + Working Group, European Association for Haemophilia and Allied Disorders, Brussels, Belgium.
Laura QuintasWomen & Girls with Bleeding Disorders + Working Group, European Association for Haemophilia and Allied Disorders, Brussels, Belgium.
Karin P M van GalenWomen & Girls with Bleeding Disorders + Working Group, European Association for Haemophilia and Allied Disorders, Brussels, Belgium.
Michelle LavinIrish Centre for Vascular Biology, School of Pharmacy & Biomedical Sciences, RCSI, Dublin, Ireland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Despite autosomal inheritance, females are disproportionately impacted by von Willebrand disease (VWD) due to heavy menstrual bleeding (HMB). HMB remains the most frequently reported and severe bleeding symptom in females with VWD. Nevertheless, interventional studies of VWD prophylaxis frequently fail to include or report menstrual-related outcomes. Objectives: This study evaluated the inclusion of menstrual and female-specific outcomes in clinical interventional trials of VWD prophylaxis. Methods: US (Clinicaltrials.gov), Canadian (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/health-canada-clinical-trials-database.html), and European (clinicaltrialsregister.eu) databases were searched for VWD interventional studies open to females with VWD aged >12 years between 2014 and 2024. Two reviewers assessed all studies, excluding those not focused on prophylaxis or duplicates. Inclusion criteria, outcomes, and publications were reviewed for menstrual-related data. Results: Initially, 42 interventional studies were identified; following exclusions, 10 studies remained. Only 2 of 10 (20%) studies incorporated menstrual inclusion criteria. Furthermore, 4 of 10 studies specifically excluded treated menstrual bleeding in their bleed eligibility criteria. Annualized bleeding rates were collected in 8 of 10 (80%) studies but menstrual outcomes in only 4 of 10 (40%). Most studies with results posted ( Conclusion: Clinical trials in VWD frequently use outcomes adapted from hemophilia studies (eg, annualized bleeding rates) rather than tailoring to the needs of females with VWD. Until we address this issue, we will lack clarity on optimal treatment, including the role of prophylaxis for the management of HMB in females with VWD.

Indexed as

MenorrhagiaMenstruationvon Willebrand DiseasesClinical Trials as TopicFemaleHumansTreatment Outcomeclinical trialfemalemenstruationtreatment outcomevon Willebrand disease

Identifiers

PMID42254459
PMCPMC13240810

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.