Leonurus heterophyllus injection in preventing post-abortion hemorrhage after induced abortion: a multi-center, prospective, randomized controlled trial

Abstract Objective The aim of this study was to evaluate the efficacy and safety of leonurus heterophyllus injection (LHI, 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: LHI group who received intramuscular LHI 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 LHI group compared with on-treatment group in Full Analysis Set (FAS) and Per Protocol Set (PPS) populations (P Conclusions LHI 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.