Objective: The aim of this study was to evaluate the efficacy and safety of motherwort injection (MI, Yi mu cao) in preventing post-abortion hemorrhage and promoting uterine retraction after induced abortion surgery.
Methods: In this multi-center randomized controlled trial undertaken between September 2014 and August 2016, 408 child-bearing age women who underwent induced abortion surgery and randomly assigned to two groups: MI group who received intramuscular MI treatment (n = 207) and no-treatment group (n = 201). The volume of vaginal bleeding and its duration were used as primary end points; and uterine size and dimension were measured as secondary end points. Blood coagulation indices, routine blood and adverse events were recorded to evaluate the safety.
Results: The efficacy analysis was based on 366 patients. No significant difference were found in baseline characteristics between the two groups (P > 0.05). The amount of vaginal bleeding and duration of bleeding were significantly reduced in MI group compared with on-treatment group in Full Analysis Set (FAS) and Per Protocol Set (PPS) populations (P < 0.001). The volume and perimeter of the uterine dimensions in MI group were smaller than no-treatment group (P < 0.001). No significant abnormal vital signs were observed. Only 1 case of mild, transient erythema was found in MI group.
Conclusions: MI could reduce post-abortion hemorrhage and improve uterine retraction in women undergoing surgical induced abortion, without serious adverse events. It was a safe and effective treatment in preventing post-abortion hemorrhage after induced abortion.
Keywords: Blood loss; Motherwort injection; Post-abortion hemorrhage; Uterine retraction; Yi Mu Cao.
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