Objective: to describe the incidence and characteristics of patient safety incidents in midwifery-led care for low-risk pregnant women. Design: multi-method study. Setting: 20 midwifery practices in the Netherlands; 1,000 patient records. Population: low-risk pregnant women. Methods: prospective incident reporting by midwives during 2 weeks; questionnaire on safety culture and retrospective content analysis of 1,000 patient records in 2009. Main outcome measures: incidence, type, impact and causes of safety incidents. Results: in the 1,000 patient records involving 14,888 contacts, 86 safety incidents were found with 25 of these having a noticeable effect on the patient. Low-risk pregnant women in midwifery care had a probability of 8.6% for a safety incident (95% CI 4.8-14.4). In 9 safety incidents, temporary monitoring of the mother and/or child was necessary. In another 6 safety incidents, reviewers reported psychological distress for the patient. Hospital admission followed from 1 incident. No safety incidents were associated with mortality or permanent harm. The majority of incidents found in the patient records concerned treatment and organisational factors. Conclusions: a low prevalence of patient safety incidents was found in midwifery care for low-risk pregnant women. This first systematic study of patient safety in midwifery adds to the base of evidence regarding the safety of midwifery-led care for low-risk women. Nevertheless, some areas for improvement were found. Improvement of patient safety should address the better adherence to practice guidelines for patient risk assessment, better implementation of interventions for known lifestyle risk factors and better availability of midwives during birthing care. © 2011 Elsevier Ltd.