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April 18, 2026Nature and Science of Sleep0 citationsOpen Access

Development of a Stepped-Care Pathway for Managing Willis-Ekbom Disease/Restless Legs Syndrome During Pregnancy: A Best Evidence Synthesis

FZFei-Yi Zhao LYLi-Ping YueSanda University RCRussell ConduitRMIT University

Key Points

This study aims to synthesize evidence on managing Willis-Ekbom disease/restless legs syndrome during pregnancy and develop a clear care pathway.
Systematic evidence retrieval guided by the 6S evidence pyramid.
Inclusion of literature published until December 2025.
Independent screening and appraisal of evidence by four reviewers.
Extraction and synthesis conducted by two sleep medicine physicians using the JBI Grading System.
Formulated 27 practice recommendations from nine included publications.
Recommendations cover five core domains: aggravating factor management, preconception counseling, iron supplementation, non-pharmacological treatments, and pharmacological treatments.
Stepped-care strategy prioritizes non-pharmacological interventions and restricts pharmacological therapy to severe cases.

Abstract

Background and Aims: Pregnancy-related Willis-Ekbom disease/restless legs syndrome (WED/RLS) is associated with adverse maternal outcomes, such as preeclampsia, an elevated risk of cesarean delivery, and perinatal depression. Although several guidelines address the management of WED/RLS, most target the general population, with only limited and fragmented recommendations specifically for pregnant women. Furthermore, existing guidelines vary substantially in quality and evidentiary basis, hindering the development of a clear, actionable care pathway for gestational WED/RLS. This study therefore aimed to systematically retrieve, appraise, and synthesize available evidence on the management of WED/RLS during pregnancy to inform obstetric clinical care practice. Methods: Evidence retrieval was guided by the 6S evidence pyramid, using a top-down approach to identify relevant guidelines, expert consensus statements, evidence summaries, clinical decision aids, systematic reviews, and meta-analyses. Literature published from database inception to December 2025 was included. Four reviewers independently screened and appraised the evidence. Evidence extraction and synthesis were subsequently conducted by two sleep medicine physicians using the JBI Grading of Evidence and Recommendation System. Results: From nine included publications (three guidelines, two evidence summaries, three clinical decision aids, and one algorithm), 27 practice recommendations were formulated. These span five core domains: (1) avoidance and management of aggravating factors, (2) preconception counselling and health education, (3) iron supplementation, (4) non-pharmacological treatments, and (5) pharmacological treatments. Together, they outline a stepped-care management strategy for gestational WED/RLS, progressing from pre-pregnancy prevention, through post-diagnosis prioritization of non-pharmacological interventions alongside iron repletion, to pharmacological therapy—restricted to the lowest effective dose and shortest necessary duration in the second or third trimester—only for severe, refractory cases. Conclusion: This study proposes a stepped-care pathway for managing pregnancy-related WED/RLS. Implementation should align recommendations with patient preferences and locally available healthcare resources to ensure contextual applicability and clinical utility. Keywords: iron supplementation, RLS/WED, clinical practice guidelines, pregnant, sleep disorder, summary of evidence

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