Safety and Effectiveness of Motherwort Injection for Hemostasis and Menstrual Regulation: Protocol for a Prospective, Observational, Multicenter Real-World Study

Abstract Background Motherwort injection (MI) is a traditional Chinese medicine injection widely used for hemostasis and menstrual regulation in obstetrics and gynecology. Although clinical trials and systematic reviews have demonstrated its effectiveness for specific indications, comprehensive real-world evidence (RWE) regarding its safety, effectiveness, and use patterns across diverse clinical settings remains limited. Objective This study aims to evaluate the safety and effectiveness of MI in routine clinical practice and to generate RWE to support its rational use in women receiving treatment for approved obstetric and gynecological indications. Methods This prospective, observational, multicenter real-world registry study plans to enroll 20,000 patients receiving MI for approved obstetric and gynecological indications in routine clinical practice in China. Treatment decisions, including whether to use MI and the dose and duration of treatment, as well as the use of concomitant medications, are made independently by treating physicians. Safety outcomes include the occurrence, type, severity, and incidence of adverse events and adverse drug reactions (ADRs). Effectiveness outcomes are assessed according to the clinical indication and include perioperative bleeding, postpartum hemorrhage, postabortion bleeding and menstrual resumption, uterine involution, menstrual regulation, and treatment satisfaction. Descriptive statistics will be used to characterize patient characteristics, MI use, and safety and effectiveness outcomes. Prespecified subgroup analyses will examine heterogeneity across major clinical groups. An exploratory nested case-control analysis with 1:4 matching and conditional logistic regression will be used to investigate factors associated with the occurrence of ADRs. Results This study has received funding and obtained ethics approval in March 2024 (approval P24003-PJ03). Participant recruitment began on March 31, 2026. By September 2026, a total of 774 participants had been enrolled and included in the study database. The protocol specifies a target sample size of 20,000 participants, with data collection, monitoring, and quality control being conducted according to standardized study procedures. Data analysis has not yet commenced, and the study findings are expected to be published in October 2027. Conclusions This study will provide large-scale RWE regarding the safety and effectiveness of MI in obstetric and gynecological practice. The findings are expected to support postmarketing safety surveillance, optimize clinical decision-making, and contribute to the evidence-based evaluation of traditional Chinese medicine injections.