Wan-Ting Xia1, Hang Zhou1, Ying Wang2, Hui-Quan Hu3, Zhi-Hong Xu4, Si-Wei Li5, Ling Shi6, Ye-Fang Huang6, De-Xin Chen7, Qian Zeng8. 1. School of Clinical medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China. 2. Department of Gynecology and Obstetrics, East ward of Sichuan Provincial People's Hospital, Chengdu, China. 3. Department of Obstetrics and Gynecology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College, Nanchong, China. 4. Department of Gynecology and Obstetrics, People's Hospital of Deyang City, Deyang, China. 5. Department of Gynecology and Obstetrics, The First Hospital of Liangshan, China. 6. Department of Gynecology, Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, P.R. China. 7. Department of Gynecology, Sichuan Provincial Hospital for Women and Children, Chengdu, China. 8. Department of Gynecology, Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, P.R. China. Electronic address: zengqian999@163.com.
Abstract
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.
RCT Entities:
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.