摘要
for about 20%of all clinically confirmed pregnancy.It is the main cause of early abortion.Vaginal bleeding is the main clinical manifestation,which seriously affects the mental health and quality of life of pregnant women.Currently,there is effective treatment for this condition.A recent meta-analysis showed that Shoutai Pill(ST Pill),a traditional Chinese medicine(TCM)formula,can effectively decrease the rate of threatened abortion.However,high heterogeneity was found among the studies included in the meta-analysis,this conclusion on the efficacy of TCM is not definitive.Although several have been conducted,some of them do not describe randomization and blinding methods.To address these problems,this article proposes an improved clinical treatment scheme based on ST Pill,which is to be tested through a well-designed randomized controlled trial,for the treatment of threatened abortion.Methods:This is a double-blinded,randomized,placebo-controlled trial to be conducted in a public Three-A hospital in China's Mainland.A total of 200 people will be enrolled.Using computer-generated random numbers,the participants will be randomly divided into two groups at a ratio of 1:1(treatment group(treated with ST Pill group)and placebo group).Both groups will receive medication to the end of the 20th gestational week or 1 week after vaginal bleeding stops,depending on which is longer.Participants in the treatment group will be treated with ST Pill(20 pills/time,once a day),and those in the placebo group will receive a placebo drug which is similar in appearance and smell with ST Pill.The main observation index is the live birth rate.Discussion:Although the efficacy of ST Pill in threatened abortion is well-known,no study has tested its efficacy through a double-blinded,randomized trials.Therefore,there is an urgent need for a standardized randomized double-blinded controlled trial to evaluate the clinical efficacy of ST Pill.ST Pill is likely to be a convenient and effective TCM pill for the prevention of threatened abortion.
