ABSTRACT
OBJECTIVE: To evaluate the efficacy and safety of motherwort(herba leonuri)injection in the treatment of fetal membrane retention after vaginal delivery.METHODS: The prospective study was designed as a multicenter,open,randomized,controlled research from December 2017 to October 2018.A total of 244 women who achieved fullterm vaginal delivery were enrolled from 7 tertiary hospitals in China.Sixteen people were lost to follow-up(7 in the experimental group and 9 in the control group).All cases were randomly divided into group of motherwort(experimental group)and group of basic treatment(control group).Full Analysis Set(FAS)and Per ProtocolSet(PPS)were used for statistical analysis.The results of main validity indicators were the same.Therefore,only the results of PPS set analysis were reported in detail.PPS set included 109 cases in control group and 114 cases in experimental group.Control group were administered by oxytocin 20 U and cephalosporinⅡintravenous injection daily for3 days after birth;experimental group were administered by motherwort 20 mg intramuscular injection per 12 hours for 5 consecutive days on the basis of basic treatment.Both groups of patients were given oral herb medicine Chan-fu-kang or Chan-fu-an Granules after discharge for 7 consecutive days.The following clinical parameters were collected and analyzed for evaluation of the efficacy and safety of motherwort injection in the treatment of retained fetal membrane after vaginal delivery.The main effectiveness indicators were maternal lochia,uterine volume change,and discharge of retained fetal membrane;the secondary effectiveness indicators were the maternal infection-related factors and infections,the incidence of secondary postpartum hemorrhage,postpartum body temperature changes,and the use of other hemostatic drugs.Safety indicators were laboratory tests(blood routine,electrocardiogram),adverse reactions/events,which were used to evaluate the safety and efficacy of motherwort injection in the treatment of retained fetal membrane after vaginal delivery.RESULTS:(1)Lochia:the duration of bloody lochia was significantly shorter in the experiment group than in the control group([(5.12±1.83)d]vs.(6.27±2.07)d,P=0.000);rate of termination of bloody lochia within 5 days was significantly higher in the experiment group than in the control group(64.91% vs. 35.78%,P=0.000).(2)Comparison of uterine volume:the reduction of uterus volume in the experiment group was significantly greater than that in the control group(Z=-2.27,P8.0 mg/L or PCT>0.5 ng/L was defined as infection,the infection rate of the experiment group after 5 days of treatment was significantly lower than that of the control group(P0.05).No other hemostatic drugs were used in the two groups,and no secondary postpartum hemorrhage occurred.(6)There were no adverse reactions reported in both groups,and no abnormal blood routine indicators or electrocardiogram appeared.CONCLUSION: The application of motherwort injection combined with the basic treatment after the vaginal delivery can significantly shorten the duration of bloody lochia,promote uterine involution,increase the discharge rate of retained fetal membrane,and reduce the rate of uterine curettage.