threatened abortion
Conditions
Interventions
The experimental group:Zhuyun Pill + Dydrogesterone
The control group:Zhuyun Pill placebo + Dydrogesterone
Sponsors
The Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
25 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 25 to 40 years old; 2. Positive urine pregnancy test or blood HCG test; 3. Early pregnancy (5-8 weeks/35-56 days), vaginal bleeding, cervical closure, with or without abdominal pain, ultrasound diagnosis confirmed intrauterine embryo or fetal survival; 4. It is consistent with the diagnosis of traditional Chinese medicine kidney deficiency type/spleen kidney deficiency type fetal leakage or fetal restlessness; 5. This threatened miscarriage did not receive treatment; 6. The subject and their spouse are capable and willing to sign informed consent; 7. Accept random grouping and take medication according to the research protocol until 10 weeks (70 days) of pregnancy.
Exclusion criteria
Exclusion criteria: 1. Multiple pregnancies (including twins). 2. Recurrent miscarriage (>=3 previous miscarriages, including biochemical miscarriage and intrauterine miscarriage 6 weeks after the last menstrual cycle). 3. Ectopic pregnancy (non intrauterine pregnancy with suspected adnexal masses or large amounts of pelvic free fluid). 4. Pregnancy at unknown locations, including HCG levels above 2500m IU/ml, but no intrauterine or ectopic pregnancy was observed. 5. Non viable fetal pregnancy, defined as: ? Intrauterine pregnancy in which fetal buds are visible but fetal heartbeat is not monitored (>49 days); ? Or any gestational sac with a diameter greater than 20mm but no yolk sac; ? No normal gestational sac is observed at 5 weeks of pregnancy, or no normal yolk sac is observed at 5.5-6 weeks of pregnancy, or no fetal heart beat is observed at 7 weeks of pregnancy; ? HCG levels continued to decrease before screening access to randomization; ? Persistent decrease in blood HCG levels or plateau (with a growth rate of=7.5% or random blood glucose>16.7nmol/L), uncontrolled hypertension, systemic lupus erythematosus, malignant tumors, severe liver and kidney diseases, depression, uncontrolled hypothyroidism, uncontrolled epilepsy, and galactose intolerance Lapp lactase deficiency or glucose galactose absorption disorder are rare genetic diseases. 12. Individuals who are allergic to the components of dexmedroxyprogesterone, Zhuyun Pill, and Zhuyun Pill placebo. 13. Known current/recent history of alcoholism or illegal drug use. 14. Known chromosomal karyotype abnormalities in parents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early pregnancy embryo survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood ß-hCG;progesterone;estradiol; | — |
Countries
China
Contacts
Public ContactLuo Songping
The Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed