Objective: To observe the clinical efficacy of modified Shoutaiwan for threatened abortion with uterine hemorrhage in early pregnancy

and investigate its mechanism. Method: The 146 patients with threatened abortion with uterine hemorrhage in early pregnancy who were dialectical to deficiency of the kidney and blood stasis in traditional Chinese medicine (TCM) were randomly divided into treatment group and control group. Patients in control group took dydrogesterone tablets orally and progesterone by intramuscular injection. Patients in treatment group also received modified Shoutaiwan based on the treatment in control group. The treatment course lasted for ten days in both groups

and followed up until thenuchal translucency (NT) examination. The clinical efficacy

TCM symptom scores

progesterone (P) and estrodiol (E2) in serum and the result of NT were compared between two groups. Result: The cumulative effective rate was 84.2%in treatment group

higher than 70.0% in control group (P<0.05). All of the TCM symptom scores in the treatment group were much lower than those in the control group after treatment (P<0.01). The level of P in serum in the treatment group was higher than that in control group after treatment (P<0.01). There was no statistically significant difference in NT results between two groups and the use of modified Shoutaiwan did not cause the increased rate of fetal abnormalities. Conclusion: Modified Shoutaiwan can safely and effectively treat the patients with threatened abortion with uterine hemorrhage in early pregnancy who were dialectical to the deficiency of kidney and blood stasis in traditional Chinese medicine.