Using Chinese herbal medicine and progesterone to prevent miscarriage

Chinese Herbal Medicine and/or Oral Progesterone for Live Births in Threatened Miscarriage: An International Cooperative Multicenter Randomized Controlled Trial (CHOP-IT)

This study is testing whether a combination of Chinese herbal medicine and progesterone can help women with vaginal bleeding and a healthy pregnancy avoid miscarriage and have a live birth.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1656 (estimated)
• Ages: 20 Years to 37 Years
• Sex: Female
• Sponsor: Heilongjiang University of Chinese Medicine (Academic / other)
• Locations: 22 sites (Hefei, Anhui and 21 other locations)
• Trial ID: NCT02633878 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of Chinese herbal medicine (New Shoutai Wan) and oral micronized progesterone in preventing miscarriage in women experiencing threatened miscarriage. It employs a two by two factorial, placebo-controlled randomized design to compare the outcomes of different treatment combinations. The primary goal is to determine which treatment regimen is most likely to result in a live birth for women with vaginal bleeding and a viable fetus. The study will also assess the safety of these interventions.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 20-37 who are experiencing threatened miscarriage with a viable fetus.

Not a fit: Patients with multiple pregnancies, ectopic pregnancies, or non-viable pregnancies will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for women at risk of miscarriage.

How similar studies have performed: While there is limited evidence on the effectiveness of these specific interventions, similar approaches using progesterone have shown promise in other studies.

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.

Where this trial is running

Hefei, Anhui and 21 other locations

• First Affiliated Hospital of Anhui University of Chinese Medicine — Hefei, Anhui, China (Completed)
• Guangdong Provincial Hospital of Chinese Medicine — Guangzhou, Guangdong, China (Completed)
• Shenzhen Hospital of Beijing University — Shenzhen, Guangdong, China (Completed)
• Daqing Longnan Hospital — Daqing, Heilongjiang, China (Completed)
• First Affiliated Hospital, Heilongjiang University of Chinese Medicine — Harbin, Heilongjiang, China (Completed)
• Luoyang Hospital of Traditional Chinese Medicinel — Luoyang, Henan, China (Recruiting)
• First Affiliated Hospital, Hunan University of Chinese Medicine — Changsha, Hunan, China (Completed)
• Changzhou Hospital of Chinese Medicine — Changzhou, Jiangsu, China (Completed)
• Siyang People's Hospital — Suqian, Jiangsu, China (Completed)
• Suqian Obstetrics and Gynecology Hospital — Suqian, Jiangsu, China (Completed)
• Xuzhou Central Hospitall — Xuzhou, Jiangsu, China (Completed)
• Xuzhou Maternal and Child Health Hospital — Xuzhou, Jiangsu, China (Completed)
• Jiangxi Maternal and Child Health Hospital — Nanchang, Jiangxi, China (Recruiting)
• The Second Affiliated Hospital of Jiangxi University of Chinese Medicine — Nanchang, Jiangxi, China (Completed)
• Dalian Maternal Hospital — Dalian, Liaoning, China (Completed)
• Dalian Municipal Women And Children's Medical Center — Dalian, Liaoning, China (Completed)
• Affiliated Hospital, Liaoning University of Chinese Medicine — Shenyang, Liaoning, China (Completed)
• Ningxia Hui Autonomous Region Hospital of traditional Chinese Medicine — Yinchuan, Ningxia Hui Autonomous Region, China (Completed)
• Taian City Central Hospital — Tai'an, Shandong, China (Completed)
• Shanxi Province Hospital of Chinese Medicine — Taiyuan, Shanxi, China (Completed)
• Hangzhou Hospital of Chinese Medical — Hangzhou, Zhejiang, China (Completed)
• Wenzhou Hospital of Chinese Medicine — Wenzhou, Zhejiang, China (Completed)

Study contacts

• Study coordinator: Xiaoke Wu, Ph.D

Conditions Threatened Miscarriage; Micronized Progesterone; Chinese Herbal Medicine; Live Birth