Achieving optimal care for women of childbearing age living with chronic diseases

The lack of evidence around medication use in pregnancy leaves many women with chronic diseases facing difficult choices about whether, and how, to start a family.

Context

Medication is rarely tested in pregnant women, so evidence to support clinical decisions is often lacking. Without robust data, clinical decisions are often based on fear of potentially harming the unborn child. This affects not only pregnant women, but any woman who could potentially become pregnant – in other words, all women of childbearing age.

Women living with chronic diseases are particularly affected, as they may require ongoing medication to manage their health. But the lack of research or regulatory clarity means healthcare professionals do not have enough evidence on the use of medication before and during pregnancy. This leads to clinical decisions being based largely on precaution and anecdotal evidence.

There is a tendency to view treatment as potentially harmful to the fetus, but risk is relative: leaving a disease untreated may cause harm to the woman, the unborn child or to both of them. This dilemma may lead healthcare professionals to give conflicting information, leaving women feeling that they must choose between managing their disease and having a child.

Despite the lack of evidence, almost half of pregnant women will take at least one medication over the course of their pregnancy. Recent years have seen some progress in research around medical treatment in pregnancy, and it is now time for clinical practice to follow.

All stakeholders must work together to shift mindsets, revise ethical and regulatory frameworks and create innovative partnerships to collect evidence to guide clinical care that will align with women’s fertility goals.

When data are limited, pregnant women lose. They may be dosed incorrectly, or medicines can be withheld from them. Wrongful assumptions are made in the absence of data.

Dr Anne Lyerly, US

What we’ve achieved

HPP worked with a group of experts from across Europe and the US to develop a policy report on achieving optimal care for women of childbearing age who are living with a chronic disease. We identified four pillars of action required to improve care for this group of women:

develop a revised ethical framework for research and care
support data collection
train healthcare professionals on person-centred care and clinical recommendations
increase awareness of these issues among women, healthcare professionals and policymakers.

The report details the actions required within each pillar to break the cycle of lack of information around medication use in pregnancy and start providing optimal, evidence-based care for all women.

Key partners and stakeholders

We are grateful to the following experts for sharing their knowledge in interviews and providing comments to a working draft:

Silvia Fernandez Barrio, Member at Large, International Federation of Psoriasis Associations (IFPA) Board, Sweden; President, Asociación Civil para el Enfermo de Psoriasis, Argentina
Nele Caeyers, Patient Research Partner and former Chair (2017–19), European League Against Rheumatism (EULAR) Standing Committee of People with Arthritis/Rheumatism in Europe (PARE); Communications Manager and Patient expert, ReumaNet, Belgium
Sophie Dupont, Head of the Neurological Rehabilitation Unit, University Hospitals Pitié Salpêtrière, France
Rebecca Fischer-Betz, Deputy Director, Department of Rheumatology & Hiller‑Research Unit Rheumatology, Medical Faculty, Heinrich-Heine‑University Düsseldorf; Project Lead, European Network of Pregnancy Registers in Rheumatology (EuNeP), Germany
Rieke van der Graaf, Associate Professor Medical Ethics, University Medical Center Utrecht, Julius Center, Netherlands
Maxine Lancelot, Scientific Officer, IFPA, Sweden

Juan Antonio Martínez López, Rheumatologist, Hospital Universitario Fundación Jiménez Díaz; Coordinator, Working group AFRODITA (on rheumatic diseases in women of childbearing age) of the Spanish Society of Rheumatology, Spain
Anne Lyerly, Professor of Social Medicine and Associate Director, Center for Bioethics, University of North Carolina, Chapel Hill; Founder, Second Wave Initiative, US
Joan Morris, Professor of Medical Statistics, Population Health Research Institute, St George’s University of London; member of the Steering Group, EUROmediCAT; Scientific Leader, EUROCAT, UK
Manuel Toledo, Neurologist, Vall d’Hebron University Hospital; member of the Steering Committee, Spanish Epilepsy Society; Secretary, Epilepsy Group for the Spanish Neurology Society, Spain; member of the Steering Committee, International Bureau for Epilepsy
Patrik Vuorio, Executive Director, IFPA, Sweden
Monika Østensen, Rheumatologist, Department of Rheumatology, Sörlandet Hospital, Kristiansand, Norway

Project funding

The work was proposed and financially supported by UCB. The opinions and conclusions expressed or implied in the report are those of the authors and/or quoted experts, and do not necessarily reflect those of UCB. The material has undergone a courtesy review by UCB.

Achieving optimal care for women of childbearing age living with chronic diseases

The lack of evidence around medication use in pregnancy leaves many women with chronic diseases facing difficult choices about whether, and how, to start a family.

Context

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What we’ve achieved

Key partners and stakeholders

Project funding

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