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Can herbal medicine and hormones prevent miscarriage? major trial reveals results

NCT ID NCT02633878

Disease control Sponsor: Heilongjiang University of Chinese Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a Chinese herbal formula (New Shoutai Wan) and/or the hormone progesterone could help women with threatened miscarriage—bleeding in early pregnancy—have a live birth. Over 1,600 women participated. The goal was to see if these treatments, alone or together, improve the chance of a successful pregnancy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,656 people

The number who actually took part.

Started

Oct 2017

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 37 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: (1) an intrauterine pregnancy with a fetal pole without visualized fetal heart motion (\>49 days); (2) a gestational sac\>20 mm in any diameter without a yolk sac; (3) absence 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; (4) falling 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.

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Conditions

The condition(s) this trial relates to.

Abortion, Threatened

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Threatened miscarriage

Contacts and locations

Locations

  • Changzhou Hospital of Traditional Chinese Medicine

    Changzhou, Jiangsu, China

  • Da Qing Long Nan Hospital

    Daqing, Heilongjiang, China

  • Dalian Maternal and Child Health Hospital

    Dalian, Liaoning, China

  • Dalian women and children's medical group

    Dalian, Liaoning, China

  • First Affiliated Hospital, Heilongjiang University of Chinese Medicine

    Harbin, Heilongjiang, China

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong, China

  • Hangzhou Hospital of Traditional Chinese Medicine

    Hangzhou, Zhejiang, China

  • Jiangxi Maternity and Child Health Hospital

    Nanchang, Jiangxi, China

  • Luoyang Hospital of Traditional Chinese Medicine

    Luoyang, Henan, China

  • Ningxia Chinese Medicine Research Center

    Yinchuan, Ningxia, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, China

  • Shanxi Traditional Chinese Medical Hospital

    Taiyuan, Shanxi, China

  • Suqian Maternity Hospital

    Suqian, Jiangsu, China

  • Taian City Central Hospital

    Tai’an, Shandong, China

  • The First Affiliated Hospital of Anhui University of Chinese Medicine

    Hefei, Anhui, China

  • The First Affiliated Hospital of Hunan University of Chinese Medicine

    Changsha, Hunan, China

  • The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning, China

  • The People's Hospital of Siyang

    Suqian, Jiangsu, China

  • The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

    Nanchang, Jiangxi, China

  • Wenzhou TCM Hospital of Zhejiang Chinese Medical University

    Wenzhou, Zhejiang, China

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, China

  • Xuzhou Maternal and Child Health Hospital

    Xuzhou, Jiangsu, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.