Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 8, 2026
Date Accepted: Oct 16, 2026
Evaluation of 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 in specific indications, comprehensive real-world evidence regarding its safety, effectiveness, and utilization 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 real-world evidence supporting its rational use in women receiving treatment for approved obstetric and gynecological indications.
Methods:
This is a prospective, observational, multicenter, real-world registry study，with the aim of enrolling 20,000 patients presenting with specific obstetrical and gynecological conditions. Participants who meet the eligibility criteria for MI indications and provide informed consent will be included in the study. The enrolled patients will be administered MI intramuscularly at a dose of 1-2 mL, in accordance with the physician's therapeutic protocol. This clinical study is designed to evaluate both the safety and effectiveness of MI, focus on the incidence of adverse events(AEs) and adverse drug reactions(ADRs), as well as outcomes related to hemostasis, uterine evolution and menstrual regulation.
Results:
This study has been funded and participant recruitment began in October 2025. By May 2026, 530 participants had been enrolled and included in the study database. Recruitment is ongoing and is expected to continue until the target sample size of 20,000 participants is reached. Data collection, monitoring, and quality control procedures are being conducted in accordance with the study protocol.
Conclusions:
This study will provide large-scale real-world evidence regarding the safety and effectiveness of MI in obstetric and gynecological practice. The findings are expected to support post-marketing safety surveillance, optimize clinical decision-making, and contribute to the evidence-based evaluation of traditional Chinese medicine injections. Clinical Trial: ClinicalTrials.gov NCT06636422; https://clinicaltrials.gov/study/NCT06636422
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