ITMCTR1900002653尚未招募未知
Effect of Zhuyun Pills combined with dydrogesterone on early pregnancy outcome in threatened abortion: a multicenter randomized controlled trial
The First Affiliated Hospital of Guangzhou University of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 25 至 40（—）
- 性别
- Female
入选标准
- •(1) Age between 25 and 40 years. We exclude older women because because older women are known to have a high risk of aneuploidy abnormal embryos and abnormal genes.
- •(2) positive urine pregnancy test or blood HCG test.
- •(3) Early pregnancy (5-10 weeks/35-70 days) Vaginal bleeding, cervix closure, with or without abdominal pain, ultrasound diagnosis of intrauterine embryo or fetus survival.
- •(4) The threatened abortion was not treated.
- •(5) The subject and her spouse are capable and willing to sign informed consent.
- •(6) Subject to randomization and medication as prescribed by the study protocol until 12 weeks of gestation (84 days).
排除标准
- •(1) Multiple pregnancy (including twins).
- •(2) Recurrent abortion (spontaneous abortion >= 3 times, including biochemical abortion and intrauterine abortion after 6 weeks of last menstruation).
- •(3) Ectopic pregnancy (non-intrauterine pregnancy with suspected accessory mass or large amount of pelvic free fluid in non-intrauterine pregnancy).
- •(4) pregnancy at unknown locations, including HCG level higher than 2500 mIU/ml but no intrauterine or extrauterine pregnancy.
- •(5) Abnormal uterine anatomy and submucosal uterine fibroids (evaluated by ultrasound).
- •(6) Vaginal bleeding from the vulva, vagina or cervix that is not related to pregnancy.
- •(7) Chinese medicine has been taken in the last two months.
- •(8) Taking progesterone (oral, intramuscular, vaginal, etc.) in the last two months.
- •(9) Used drugs that cause bleeding, such as non-steroidal anti-inflammatory drugs aspirin.
- •(10) Congenital or acquired bleeding tendency (hemophilia, von Willebrand disease or use of anticoagulants, etc.).
- •(11) Suffering from major illnesses (regardless of severity), including poorly controlled diabetes, uncontrolled hypertension, systemic lupus erythematosus, untreated or active cancer (excluding any cancer in remission or non-melanoma skin cancer), liver disease, kidney disease, rheumatoid arthritis, heart disease, lung disease other than mild asthma, need medication of nervous system disease, uncontrolled hypothyroidism, uncontrolled epilepsy, Untreated vitamin B12 deficiency, severe anemia (hematocrit < 30%), gout or nasal polyps.
- •(12) Known current/recent history of alcohol abuse or taking illegal drugs.
- •(13) Known parental karyotype abnormalities.
研究者
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