Threatened MiscarriagePhase 3NCT02633878
Chinese Herbal Medicine (New "Shoutai Wan") and/or Oral Progesterone Intervention Trial for Threatened Miscarriage
A Phase 3 study testing Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone in people with Threatened Miscarriage, run by Heilongjiang University of Chinese Medicine at 22 sites in China.
Trial summary
Threatened miscarriage is manifested by vaginal bleeding, with or without abdominal pain, while the cervix is closed and the fetus is viable and inside the uterine cavity. Threatened miscarriage is a common complication of pregnancy occurring in 20% of all clinically recognized pregnancies and about half of these will… Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Threatened Miscarriage
- What is being tested?
- Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,656 participants
- Where
- 22 sitesChina
- Study dates
- 20 Oct 2017to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age of women between 20-37 years.
- Pregnant. The fetus is viable inside the uterine cavity during early pregnancy (5-10 week gestations) by ultrasound and/or serum hCG changes.
- Bleeding symptoms: vaginal bleeding with or without abdominal pain, while the cervix is closed in during speculum examination.
Who cannot join
- Multiple pregnancies (more than one gestational sac or fetal pole in ultrasonography).
- 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.
- 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.
- 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%).
- Intrauterine abnormalities or submucosal fibroids distorting uterine cavity (as assessed by ultrasound).
- Bleeding attributed to a vulvar, vaginal, or cervical source unrelated to the pregnancy.
Show all 12Show fewer
- For this threatened miscarriage, use of the same or similar Chinese medicine and/or progesterone more than one week.
- History of a congenital or acquired bleeding diathesis, i.e. Hemophilia, Von Willebrands's Disease, use of anti-coagulants, etc.
- 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.
- Known current or recent alcohol abuse or illicit drug use.
- Known abnormal parental karyotype.
- Unwilling to give informed consent.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan
Changzhou Hospital of Traditional Chinese Medicine
Changzhou, Jiangsu
Dalian Maternal and Child Health Hospital
Dalian, Liaoning
Dalian women and children's medical group
Dalian, Liaoning
Da Qing Long Nan Hospital
Daqing, Heilongjiang
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong
Hangzhou Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang
The First Affiliated Hospital of Anhui University of Chinese Medicine
Hefei, Anhui
Luoyang Hospital of Traditional Chinese Medicine
Luoyang, Henan
Jiangxi Maternity and Child Health Hospital
Nanchang, Jiangxi
The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi
The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Suqian Maternity Hospital
Suqian, Jiangsu
The People's Hospital of Siyang
Suqian, Jiangsu
Taian City Central Hospital
Tai’an, Shandong
Shanxi Traditional Chinese Medical Hospital
Taiyuan, Shanxi
Wenzhou TCM Hospital of Zhejiang Chinese Medical University
Wenzhou, Zhejiang
Xuzhou Central Hospital
Xuzhou, Jiangsu
Xuzhou Maternal and Child Health Hospital
Xuzhou, Jiangsu
Ningxia Chinese Medicine Research Center
Yinchuan, Ningxia
About this study
Official title: Chinese Herbal Medicine (New "Shoutai Wan") and/or Oral Progesterone Intervention Trial for Threatened Miscarriage (CHOP-IT): An International Cooperative Multicenter Randomized Controlled Trial
Threatened miscarriage is manifested by vaginal bleeding, with or without abdominal pain, while the cervix is closed and the fetus is viable and inside the uterine cavity. Threatened miscarriage is a common complication of pregnancy occurring in 20% of all clinically recognized pregnancies and about half of these will eventually result in pregnancy loss. The goal of this two by two factorial, placebo controlled randomized trial is to determine that two oral medications and their combination, will mostly likely result in live birth in women with threatened miscarriage. We will evaluate the efficacy and safety of Chinese herbal medicine (New "Shoutai Wan", NSTW) and/or oral micronized progesterone (OP) for treating threatened miscarriage in this trial. Our primary outcome of this trial is live birth. We hypothesize that: 1. treatment with NSTW plus OP or OP placebo is more likely to result in live birth than NSTW placebo plus OP or placebo; 2. treatment with OP plus NSTW or NSTW placebo is more likely to result in live birth than OP placebo plus NSTW or NSTW placebo; 3. treatment with combination of NSTW and OP is more likely to result in live birth than combination of NSTW placebo and OP placebo.
Read the detailed description
The causes of spontaneous miscarriage are diverse and comprise chromosomal, genetic, anatomical, immunological, hormonal, infectious and psychological factors, the other factors contribute to an increased risk include advancing paternal and maternal age and mothers with systemic diseases, such as diabetes or thyroid dysfunction. The incidence is difficult to determine precisely because it occurs very early during a pregnancy and almost 30% of early pregnancy may go unrecognized; the pathogenesis of pregnancy loss in this condition is still remains obscure. Compared with healthy women, the women with threatened miscarriage were found not only to have increased rate of antepartum haemorrhage, prelabour rupture of the membranes, preterm delivery, and intrauterine growth restriction, but also suffer from significant psychological impairment including considerable anxiety and stress, depression, sleep disturbances, anger, and marital disturbances.
To date, therapies have limited effectiveness in treating threatened miscarriage and are empirical. Bed rest does not prevent pregnancy loss. Acetaminophen may have some effects on relieving pain only. The most commonly used prescription medication was human chorionic gonadotropin (hCG), maintaining the luteotrophic effects to support continued secretion of estrogen and progesterone, but it's beneficial effects still cannot be verified. Progesterone is another most commonly used standard medication, maintaining the endometrial proliferation and preventing poor decidualization. A number of recent studies in women with threatened miscarriage shown a reduction in pregnancy loss with progesterone treatment. But progestogens are a group of hormones, including both the natural female sex hormone progesterone and the synthetic forms. Micronized progesterone is a kind of progesterone; it is structurally and pharmacologically very similar to natural progesterone and has good oral bioavailability. It is especially suitable for women with threatened miscarriage as it does not have androgenic or oestrogenic effects on the foetus. A recent review of maternal use of micronized progesterone during pregnancy also found no evidence for an increased risk of congenital malformations. However it may only be suitable to treat women with threatened miscarriage who have low progesterone levels due to corpus luteum deficiency at the first trimester of pregnancy. There is no evidence to show the beneficial effects of progesterone to treat threatened miscarriage due to others factors. At the same time, progesterone treatment is also expensive. New or adjuvant treatments that are suitable, readily accessible, affordable, and safe are needed to treat women with threatened miscarriage.
- Conditions
- Threatened Miscarriage
- Being tested
- Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone, Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone Placebo, Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral Progesterone, Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral Progesterone Placebo
- Keywords
- Threatened Miscarriage, Micronized Progesterone, Chinese Herbal Medicine, Live Birth
- Medical subject headings
- Abortion, Threatened
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Herbal Medicine (New "Shoutai Wan") plus Oral ProgesteroneDrug
Chinese Herbal Medicine (New "Shoutai Wan", one pack twice daily) + Oral Progesterone (100 mg thrice daily)
Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone PlaceboDrug
Chinese Herbal Medicine (New "Shoutai Wan", one pack twice daily) + Oral Progesterone Placebo (100 mg thrice daily)
Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral ProgesteroneDrug
Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo, one pack twice daily) + Oral Progesterone (100 mg thrice daily)
Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral Progesterone PlaceboDrug
Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo, one pack twice daily) + Oral Progesterone Placebo (100 mg thrice daily)
| Study group | Role | What they receive |
|---|---|---|
| NSTW + OP | Experimental | NSTW one pack twice daily until 12 weeks of gestations (max 84 days); OP 100 mg thrice daily until 12 weeks of gestations (max 84 days). Receives: Drug: Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone |
| NSTW + OP placebo | Experimental | NSTW one pack twice daily until 12 weeks of gestations (max 84 days); OP Placebo 100 mg thrice daily until 12 weeks of gestations (max 84 days). Receives: Drug: Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone Placebo |
| NSTW Placebo + OP | Experimental | NSTW Placebo one pack twice daily until 12 weeks of gestations (max 84 days); OP 100 mg thrice daily until 12 weeks of gestations (max 84 days). Receives: Drug: Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral Progesterone |
| NSTW Placebo + OP Placebo | Placebo comparator | NSTW Placebo one pack twice daily until 12 weeks of gestations (max 84 days); OP Placebo 100 mg thrice daily until 12 weeks of gestations (max 84 days). Receives: Drug: Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral Progesterone Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth
Rate of live birth at or beyond 20 completed weeks' gestation
Measured: At or beyond 20 completed weeks' gestation
Secondary outcomes (18)
Pregnancy outcome: Ongoing pregnancy
Rate of ongoing pregnancy (beyond 12 weeks' gestation)
Measured: Beyond 12 weeks' gestation
Pregnancy outcome: Miscarriage during the first trimester
Rate of miscarriage during the first trimester (at or before 12 weeks' gestation)
Measured: During the first trimester (at or before 12 weeks' gestation)
Pregnancy outcome: Miscarriage during second and third trimesters
Rate of miscarriage during second and third trimesters (beyond 12 weeks' gestation until 20 weeks)
Measured: During second and third trimesters (beyond 12 weeks' gestation until 20 weeks)
Pregnancy outcome: Termination
Rate of termination at any time during treatment and follow-up period
Measured: At any time during treatment (up to 2 months) and follow-up period (up to 1 year)
Pregnancy outcome: Stillbirth
Rate of stillbirth (at or beyond 20 weeks' gestation)
Measured: At or beyond 20 weeks' gestation
Pregnancy outcome: Induced abortion
Rate of induced abortion at any time during treatment and follow-up for any reasons
Measured: At any time during treatment (up to 2 months) and follow-up period (up to 1 year)
Pregnancy outcome: Gestational age at delivery
Gestational age at delivery (weeks and days)
Measured: Up to 1 day after delivery
Pregnancy outcome: Preterm birth
Rate of preterm birth (birth beyond 28 week and before 37 completed weeks' gestation (up to and including 36 weeks and 6 days of gestation))
Measured: Birth before 37 completed weeks' gestation (up to and including 36 weeks and 6 days of gestation)
Pregnancy outcome: Extreme preterm birth
Rate of extreme preterm birth (birth beyond 20 weeks and before 28 completed weeks' gestation (up to and including 27 weeks and 6 days of gestation))
Measured: Birth beyond 20 weeks and before 28 completed weeks' gestation (up to and including 27 weeks and 6 days of gestation)
Pregnancy outcome: Full-term birth
Rate of full-term birth (at or beyond 37 weeks' gestation, and before 42 weeks' gestation)
Measured: At or beyond 37 weeks' gestation, and before 42 weeks' gestation
Pregnancy outcome: Post-term birth
Rate of post-term birth (at or beyond 42 weeks' gestation)
Measured: At or beyond 42 weeks' gestation
Neonatal outcome: Birth weight
Birth weight of neonatal (adjusted for gestational age and sex by Chinese standards)
Measured: When neonatal is born
Neonatal outcome: Small for gestational age
Rate of small for gestational age when neonatal is born
Measured: When neonatal is born
Neonatal outcome: Large for gestational age
Rate of large for gestational age when neonatal is born
Measured: When neonatal is born
Neonatal outcome: Congenital malformation
Rate of congenital malformation
Measured: At any time during treatment (up to 2 months) and follow-up period (up to 1 year)
Other outcome: Mean score change in TCM Symptom Questionnaire
Mean score change in TCM Symptom Questionnaire from baseline to the end of intervention. The questionnaire covers many dimensions including symptoms (amount of vaginal bleeding, severity of abdominal pain and other general symptoms), emotional factors and so on. The minimum and maximum value are depend on the symptoms of the patient respectively.
Measured: From date of randomization until the date of end of treatment, assessed up to 2 months
Other outcome: Mean score change in 12-Item Short-Form Health Survey
Mean score change in 12-Item Short-Form Health Survey from baseline to the end of intervention. The minimum value is 0 and the maximum value is 100, and higher scores mean a better outcome.
Measured: From date of randomization until the date of end of treatment, assessed up to 2 months
Other outcome: Mean score change in Self-Rating Anxiety Scale
Mean score change in Self-Rating Anxiety Scale from baseline to the end of intervention. The minimum value is 20 and the maximum value is 80, and lower scores mean a better outcome.
Measured: From date of randomization until the date of end of treatment, assessed up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start20 Oct 2017
- Primary completion26 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Threatened MiscarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,656 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heilongjiang University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoke Wu, Heilongjiang University of Chinese Medicine
- Investigators
- Xiao-Ke Wu, Ph.D, Study chair, First Affiliated Hospital of Heilongjiang Chinese Medicine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633878
- Sponsor's protocol ID
- CHOP-IT
- Status last verified
- Jan 2026
- First submitted
- 7 Dec 2015
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Herbal Medicine (New "Shoutai Wan") and/or Oral Progesterone Intervention Trial for Threatened Miscarriage (CHOP-IT): An International Cooperative Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02633878
- Acronym / sponsor ID
- CHOP-IT
- Conditions
- Threatened Miscarriage
- Keywords
- Threatened Miscarriage, Micronized Progesterone, Chinese Herbal Medicine, Live Birth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,656 participants (actual)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 26 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Threatened miscarriage is manifested by vaginal bleeding, with or without abdominal pain, while the cervix is closed and the fetus is viable and inside the uterine cavity. Threatened miscarriage is a common complication of pregnancy occurring in 20% of all clinically recognized pregnancies and about half of these will eventually result in pregnancy loss. The goal of this two by two factorial, placebo controlled randomized trial is to determine that two oral medications and their combination, will mostly likely result in live birth in women with threatened miscarriage. We will evaluate the efficacy and safety of Chinese herbal medicine (New "Shoutai Wan", NSTW) and/or oral micronized progesterone (OP) for treating threatened miscarriage in this trial. Our primary outcome of this trial is live birth. We hypothesize that: 1. treatment with NSTW plus OP or OP placebo is more likely to result in live birth than NSTW placebo plus OP or placebo; 2. treatment with OP plus NSTW or NSTW placebo is more likely to result in live birth than OP placebo plus NSTW or NSTW placebo; 3. treatment with combination of NSTW and OP is more likely to result in live birth than combination of NSTW placebo and OP placebo.
Detailed description
The causes of spontaneous miscarriage are diverse and comprise chromosomal, genetic, anatomical, immunological, hormonal, infectious and psychological factors, the other factors contribute to an increased risk include advancing paternal and maternal age and mothers with systemic diseases, such as diabetes or thyroid dysfunction. The incidence is difficult to determine precisely because it occurs very early during a pregnancy and almost 30% of early pregnancy may go unrecognized; the pathogenesis of pregnancy loss in this condition is still remains obscure. Compared with healthy women, the women with threatened miscarriage were found not only to have increased rate of antepartum haemorrhage, prelabour rupture of the membranes, preterm delivery, and intrauterine growth restriction, but also suffer from significant psychological impairment including considerable anxiety and stress, depression, sleep disturbances, anger, and marital disturbances.
To date, therapies have limited effectiveness in treating threatened miscarriage and are empirical. Bed rest does not prevent pregnancy loss. Acetaminophen may have some effects on relieving pain only. The most commonly used prescription medication was human chorionic gonadotropin (hCG), maintaining the luteotrophic effects to support continued secretion of estrogen and progesterone, but it's beneficial effects still cannot be verified. Progesterone is another most commonly used standard medication, maintaining the endometrial proliferation and preventing poor decidualization. A number of recent studies in women with threatened miscarriage shown a reduction in pregnancy loss with progesterone treatment. But progestogens are a group of hormones, including both the natural female sex hormone progesterone and the synthetic forms. Micronized progesterone is a kind of progesterone; it is structurally and pharmacologically very similar to natural progesterone and has good oral bioavailability. It is especially suitable for women with threatened miscarriage as it does not have androgenic or oestrogenic effects on the foetus. A recent review of maternal use of micronized progesterone during pregnancy also found no evidence for an increased risk of congenital malformations. However it may only be suitable to treat women with threatened miscarriage who have low progesterone levels due to corpus luteum deficiency at the first trimester of pregnancy. There is no evidence to show the beneficial effects of progesterone to treat threatened miscarriage due to others factors. At the same time, progesterone treatment is also expensive. New or adjuvant treatments that are suitable, readily accessible, affordable, and safe are needed to treat women with threatened miscarriage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NSTW + OP | Experimental | Drug: Chinese Herbal Medicine (New "Shoutai Wan") plus Oral ProgesteroneNSTW one pack twice daily until 12 weeks of gestations (max 84 days); OP 100 mg thrice daily until 12 weeks of gestations (max 84 days). |
| NSTW + OP placebo | Experimental | Drug: Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone PlaceboNSTW one pack twice daily until 12 weeks of gestations (max 84 days); OP Placebo 100 mg thrice daily until 12 weeks of gestations (max 84 days). |
| NSTW Placebo + OP | Experimental | Drug: Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral ProgesteroneNSTW Placebo one pack twice daily until 12 weeks of gestations (max 84 days); OP 100 mg thrice daily until 12 weeks of gestations (max 84 days). |
| NSTW Placebo + OP Placebo | Placebo comparator | Drug: Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral Progesterone PlaceboNSTW Placebo one pack twice daily until 12 weeks of gestations (max 84 days); OP Placebo 100 mg thrice daily until 12 weeks of gestations (max 84 days). |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age of women between 20-37 years.
- Pregnant. The fetus is viable inside the uterine cavity during early pregnancy (5-10 week gestations) by ultrasound and/or serum hCG changes.
- Bleeding symptoms: vaginal bleeding with or without abdominal pain, while the cervix is closed in during speculum examination.
Key exclusion criteria (12 listed)
- Multiple pregnancies (more than one gestational sac or fetal pole in ultrasonography).
- 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.
- 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.
- 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%).
- Intrauterine abnormalities or submucosal fibroids distorting uterine cavity (as assessed by ultrasound).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese Herbal Medicine (New "Shoutai Wan") plus Oral ProgesteroneChinese Herbal Medicine (New "Shoutai Wan", one pack twice daily) + Oral Progesterone (100 mg thrice daily) | Drug | NSTW + OP |
| Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone PlaceboChinese Herbal Medicine (New "Shoutai Wan", one pack twice daily) + Oral Progesterone Placebo (100 mg thrice daily) | Drug | NSTW + OP placebo |
| Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral ProgesteroneChinese Herbal Medicine Placebo (New "Shoutai Wan" placebo, one pack twice daily) + Oral Progesterone (100 mg thrice daily) | Drug | NSTW Placebo + OP |
| Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral Progesterone PlaceboChinese Herbal Medicine Placebo (New "Shoutai Wan" placebo, one pack twice daily) + Oral Progesterone Placebo (100 mg thrice daily) | Drug | NSTW Placebo + OP Placebo |
Primary outcome
Live birth
Time frame: At or beyond 20 completed weeks' gestation
Rate of live birth at or beyond 20 completed weeks' gestation
18 secondary outcomes
Pregnancy outcome: Ongoing pregnancy
Time frame: Beyond 12 weeks' gestation
Pregnancy outcome: Miscarriage during the first trimester
Time frame: During the first trimester (at or before 12 weeks' gestation)
Pregnancy outcome: Miscarriage during second and third trimesters
Time frame: During second and third trimesters (beyond 12 weeks' gestation until 20 weeks)
Pregnancy outcome: Termination
Time frame: At any time during treatment (up to 2 months) and follow-up period (up to 1 year)
Pregnancy outcome: Stillbirth
Time frame: At or beyond 20 weeks' gestation
Pregnancy outcome: Induced abortion
Time frame: At any time during treatment (up to 2 months) and follow-up period (up to 1 year)
Pregnancy outcome: Gestational age at delivery
Time frame: Up to 1 day after delivery
Pregnancy outcome: Preterm birth
Time frame: Birth before 37 completed weeks' gestation (up to and including 36 weeks and 6 days of gestation)
Pregnancy outcome: Extreme preterm birth
Time frame: Birth beyond 20 weeks and before 28 completed weeks' gestation (up to and including 27 weeks and 6 days of gestation)
Pregnancy outcome: Full-term birth
Time frame: At or beyond 37 weeks' gestation, and before 42 weeks' gestation
Pregnancy outcome: Post-term birth
Time frame: At or beyond 42 weeks' gestation
Neonatal outcome: Birth weight
Time frame: When neonatal is born
Neonatal outcome: Small for gestational age
Time frame: When neonatal is born
Neonatal outcome: Large for gestational age
Time frame: When neonatal is born
Neonatal outcome: Congenital malformation
Time frame: At any time during treatment (up to 2 months) and follow-up period (up to 1 year)
Other outcome: Mean score change in TCM Symptom Questionnaire
Time frame: From date of randomization until the date of end of treatment, assessed up to 2 months
Other outcome: Mean score change in 12-Item Short-Form Health Survey
Time frame: From date of randomization until the date of end of treatment, assessed up to 2 months
Other outcome: Mean score change in Self-Rating Anxiety Scale
Time frame: From date of randomization until the date of end of treatment, assessed up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Threatened Miscarriage
Not yet recruitingObservational study
Serum Progesterone and Threatened Abortion During Lactation
Threatened Abortion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao-Ke Wu, Ph.D study chair
First Affiliated Hospital of Heilongjiang Chinese Medicine University
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone in people with Threatened Miscarriage, run by Heilongjiang University of Chinese Medicine at 22 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth (time frame: At or beyond 20 completed weeks' gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.