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. 2021 Apr 19;2021(4):CD013792. doi: 10.1002/14651858.CD013792.pub2

ChiCTR‐IOR‐15007526.

Study name Chinese herbal medicine and micronized progesterone for threatened miscarriage: an International Cooperation multicenter randomized controlled trial
Methods 2x2 factorial randomised placebo‐controlled trial.
Participants Women aged 18 to 37 years that are currently pregnant (as confirmed by positive urinary pregnancy tests) at 5‐10 weeks of gestation, presenting with vaginal bleeding with or without abdominal pain, while the cervix is closed by visual exam and the fetus is viable inside the uterine cavity during early pregnancy. Women will have had no previous treatment for miscarriage. Exclusion criteria include women with a pregnancy of unknown location; ectopic pregnancy; multiple pregnancy; a non‐viable pregnancy; serial serum hCG levels which show a decline or a plateau, intrauterine abnormalities and fibroids distorting uterine cavity (as assessed by ultrasound); known abnormal parental karyotype; bleeding attributed to a vulvar, vaginal, or cervical source unrelated to the pregnancy; presence of a congenital or acquired bleeding diathesis; presence of contributing major medical disorders (regardless of severity). These include poorly controlled diabetes, uncontrolled hypertension, systemic lupus erythematosus (SLE), untreated or active cancer (any cancer in remission or non‐melanoma skin cancer is not included in the exclusion criteria), liver disease, renal disease, rheumatoid arthritis, cardiac disease, pulmonary disease other than mild asthma, neurological disease requiring medical treatment, uncontrolled hypothyroidism, uncontrolled seizure disorder. Untreated vitamin B12 deficiency, severe anaemia (Hct < 30%), haemophilia, gout, nasal polyps, among others; use of agents that may contribute to bleeding such as aspirin, NSAIDs; current use of Chinese Herbal Medicines (CHM) within 2 months; current use of progestins‐ oral, intramuscular, vaginal, etc within 2 months; known current or recent alcohol abuse or illicit drug use; current diagnosis of sexually transmitted infection (STI) (temporary exclusion).
Interventions Chinese herbal medicine + micronized progesterone placebo versus Chinese herbal medicine placebo + micronized progesterone versus Chinese herbal medicine + micronized progesterone versus Chinese herbal medicine placebo + micronized progesterone placebo.
Outcomes Live birth rate (> 37 weeks of gestation); early abortion; intrauterine pregnancy abortion before 20 weeks of pregnancy; intrauterine pregnancy abortion after 20 weeks of pregnancy; continuous pregnancy rate beyond 12 weeks of pregnancy; persistent pregnancy rate over 20 weeks of pregnancy; preterm birth rate (pregnancy > 24 weeks, < 37 weeks); maternal hypertension; maternal diabetes; prenatal haemorrhage; premature delivery; late pregnancy; preeclampsia; abnormal fetal testing; intrauterine growth restriction; low birthweight; stillbirth; neonatal death; congenital abnormalities; adverse reactions.
Starting date 30‐Nov‐2015
Contact information xiaokewu2002@vip.sina.com
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