Chinese Herbal Medicine and/or Oral Progesterone Intervention Trial for Threatened Miscarriage
Launched by HEILONGJIANG UNIVERSITY OF CHINESE MEDICINE · Dec 14, 2015
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the effects of Chinese herbal medicine and oral progesterone on women experiencing a threatened miscarriage, which is when a pregnant woman has vaginal bleeding but the cervix is closed and the baby is still viable. The goal is to see if these treatments can help more women have a healthy live birth compared to a placebo (a treatment that has no active ingredients). The trial is looking for women between the ages of 20 and 37 who are early in their pregnancy (5 to 10 weeks along) and have symptoms of threatened miscarriage, such as bleeding or abdominal pain.
If you participate in this trial, you may receive one of the treatments or a placebo, and you will be monitored throughout the study to assess the safety and effectiveness of the treatments. It’s important to note that certain conditions, like multiple pregnancies or ectopic pregnancies (where the pregnancy develops outside the uterus), will exclude women from participating. This study is currently recruiting participants, and it aims to provide valuable information that could help improve care for women facing the risk of miscarriage.
Gender
FEMALE
Eligibility criteria
- Inclusion criteria:
- • 1. Age of women between 20-37 years.
- • 2. Pregnant. The fetus is viable inside the uterine cavity during early pregnancy (5-10 week gestations) by ultrasound and/or serum hCG changes.
- • 3. Bleeding symptoms: vaginal bleeding with or without abdominal pain, while the cervix is closed in during speculum examination.
- Exclusion criteria:
- • 1. Multiple pregnancies (more than one gestational sac or fetal pole in ultrasonography).
- • 2. Ectopic pregnancy. We will define an ectopic pregnancy as any suspected adnexal mass or large amounts of free fluid in the pelvis without an accompanying intrauterine pregnancy.
- • 3. Pregnancies of Unknown Location (PUL). This will include pregnancies with an hCG level \>2500mIU/mL without visualization of an intrauterine or extrauterine (i.e. ectopic) pregnancies.
- • 4. Non-viable pregnancy. We will define a non-viable pregnancy as: ①an intrauterine pregnancy with a fetal pole without visualized fetal heart motion (\>49 days); ②a gestational sac\>20 mm in any diameter without a yolk sac; ③absence of a normal gestational sac at 5 weeks of pregnancy, absence of a yolk sac at 5.5-6 weeks of pregnancy, or absence of cardiac activity at 7 weeks of pregnancy by ultrasound; ④falling serum hCG values on serial visits or between baseline and randomization visit, or serial serum hCG levels which show a plateau (2-day increase ≤ 10%).
- • 5. Intrauterine abnormalities or submucosal fibroids distorting uterine cavity (as assessed by ultrasound).
- • 6. Bleeding attributed to a vulvar, vaginal, or cervical source unrelated to the pregnancy.
- • 7. For this threatened miscarriage, use of the same or similar Chinese medicine and/or progesterone more than one week.
- • 8. History of a congenital or acquired bleeding diathesis, i.e. Hemophilia, Von Willebrands's Disease, use of anti-coagulants, etc.
- • 9. 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, neurologic disease requiring medical treatment, uncontrolled hypothyroidism, uncontrolled seizure disorder. Untreated vitamin B12 deficiency, severe anemia (hct \< 30%), hemophilia, gout, nasal polyps.
- • 10. Known current or recent alcohol abuse or illicit drug use.
- • 11. Known abnormal parental karyotype.
- • 12. Unwilling to give informed consent.
- • 13. Unwillingness to be randomized.
About Heilongjiang University Of Chinese Medicine
Heilongjiang University of Chinese Medicine is a leading institution dedicated to the advancement of traditional Chinese medicine and integrative healthcare research. With a strong emphasis on clinical trials, the university aims to explore innovative therapeutic approaches, enhance evidence-based practices, and promote the global understanding of traditional healing methods. Its diverse research initiatives are supported by a team of experienced professionals and state-of-the-art facilities, fostering collaboration between academia and clinical practice to improve patient outcomes and contribute to the evolution of medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Daqing, Heilongjiang, China
Xuzhou, Jiangsu, China
Shenzhen, Guangdong, China
Xuzhou, Jiangsu, China
Nanchang, Jiangxi, China
Dalian, Liaoning, China
Taiyuan, Shanxi, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Nanchang, Jiangxi, China
Harbin, Heilongjiang, China
Tai'an, Shandong, China
Guangzhou, Guangdong, China
Dalian, Liaoning, China
Hefei, Anhui, China
Luoyang, Henan, China
Changsha, Hunan, China
Changzhou, Jiangsu, China
Suqian, Jiangsu, China
Suqian, Jiangsu, China
Xuzhou, Jiangsu, China
Dalian, Liaoning, China
Shenyang, Liaoning, China
Yinchuan, Ningxia Hui Autonomous Region, China
Hangzhou, Zhejiang, China
Patients applied
Trial Officials
Xiaoke Wu, Ph.D
Study Chair
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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