Phase
Condition
N/ATreatment
Chinese Herbal Medicine plus Oral Micronized Progesterone Placebo
Chinese Herbal Medicine Placebo plus Oral Micronized Progesterone Placebo
Chinese Herbal Medicine Placebo plus Oral Micronized Progesterone
Clinical Study ID
Ages 20-37 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Age of women between 20-37 years.
Pregnant. The fetus is viable inside the uterine cavity during early pregnancy (5-10week gestations) by ultrasound and/or serum hCG changes.
Bleeding symptoms: vaginal bleeding with or without abdominal pain, while the cervixis closed in during speculum examination.
Exclusion
Exclusion criteria:
Multiple pregnancies (more than one gestational sac or fetal pole inultrasonography).
Ectopic pregnancy. We will define an ectopic pregnancy as any suspected adnexal massor large amounts of free fluid in the pelvis without an accompanying intrauterinepregnancy.
Pregnancies of Unknown Location (PUL). This will include pregnancies with an hCGlevel >2500mIU/mL without visualization of an intrauterine or extrauterine (i.e.ectopic) pregnancies.
Non-viable pregnancy. We will define a non-viable pregnancy as: ①an intrauterinepregnancy with a fetal pole without visualized fetal heart motion (>49 days); ②agestational sac>20 mm in any diameter without a yolk sac; ③absence of a normalgestational sac at 5 weeks of pregnancy, absence of a yolk sac at 5.5-6 weeks ofpregnancy, or absence of cardiac activity at 7 weeks of pregnancy by ultrasound; ④falling serum hCG values on serial visits or between baseline and randomizationvisit, or serial serum hCG levels which show a plateau (2-day increase ≤ 10%).
Intrauterine abnormalities or submucosal fibroids distorting uterine cavity (asassessed by ultrasound).
Bleeding attributed to a vulvar, vaginal, or cervical source unrelated to thepregnancy.
For this threatened miscarriage, use of the same or similar Chinese medicine and/orprogesterone more than one week.
History of a congenital or acquired bleeding diathesis, i.e. Hemophilia, VonWillebrands's Disease, use of anti-coagulants, etc.
Presence of contributing major medical disorders (regardless of severity). Theseinclude poorly controlled diabetes, uncontrolled hypertension, systemic lupuserythematosus (SLE), untreated or active cancer (any cancer in remission ornon-melanoma skin cancer is not included in the exclusion criteria), liver disease,renal disease, rheumatoid arthritis, cardiac disease, pulmonary disease other thanmild asthma, neurologic disease requiring medical treatment, uncontrolledhypothyroidism, uncontrolled seizure disorder. Untreated vitamin B12 deficiency,severe anemia (hct < 30%), hemophilia, gout, nasal polyps.
Known current or recent alcohol abuse or illicit drug use.
Known abnormal parental karyotype.
Unwilling to give informed consent.
Unwillingness to be randomized.
Study Design
Study Description
Connect with a study center
First Affiliated Hospital of Anhui University of Chinese Medicine
Hefei, Anhui
ChinaCompleted
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong
ChinaCompleted
Shenzhen Hospital of Beijing University
Shenzhen, Guangdong
ChinaCompleted
Daqing Longnan Hospital
Daqing, Heilongjiang
ChinaCompleted
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang
ChinaCompleted
The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang 150028
ChinaSite Not Available
Luoyang Hospital of Traditional Chinese Medicinel
Luoyang, Henan
ChinaActive - Recruiting
First Affiliated Hospital, Hunan University of Chinese Medicine
Changsha, Hunan
ChinaCompleted
Changzhou Hospital of Chinese Medicine
Changzhou, Jiangsu
ChinaCompleted
Siyang People's Hospital
Suqian, Jiangsu
ChinaCompleted
Suqian Obstetrics and Gynecology Hospital
Suqian, Jiangsu
ChinaCompleted
Xuzhou Central Hospital
Xuzhou, Jiangsu
ChinaActive - Recruiting
Xuzhou Central Hospitall
Xuzhou, Jiangsu
ChinaCompleted
Xuzhou Maternal and Child Health Hospital
Xuzhou, Jiangsu
ChinaCompleted
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi
ChinaActive - Recruiting
The Second Affiliated Hospital of Jiangxi University of Chinese Medicine
Nanchang, Jiangxi
ChinaCompleted
Dalian Maternal Hospital
Dalian, Liaoning
ChinaCompleted
Dalian Maternity Hospital
Dalian, Liaoning
ChinaActive - Recruiting
Dalian Municipal Women And Children's Medical Center
Dalian, Liaoning
ChinaCompleted
Affiliated Hospital, Liaoning University of Chinese Medicine
Shenyang, Liaoning
ChinaCompleted
Ningxia Hui Autonomous Region Hospital of traditional Chinese Medicine
Yinchuan, Ningxia Hui Autonomous Region
ChinaCompleted
Taian City Central Hospital
Tai'an, Shandong
ChinaCompleted
Shanxi Province Hospital of Chinese Medicine
Taiyuan, Shanxi
ChinaCompleted
Hangzhou Hospital of Chinese Medical
Hangzhou, Zhejiang
ChinaCompleted
Hangzhou hospital of Chinese medicine
Hangzhou, Zhejiang
ChinaActive - Recruiting
Wenzhou Hospital of Chinese Medicine
Wenzhou, Zhejiang
ChinaCompleted
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