Chinese Herbal Medicine (New "Shoutai Wan") and/or Oral Progesterone Intervention Trial for Threatened Miscarriage

NCT02633878 | Completed Phase 3 DMC

• 1 other identifier: CHOP-IT
• Study Type: interventional
• Target: 1,656
• Locations: 1 country
• Sites: 22

Brief 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 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.

Conditions

Threatened Miscarriage

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Live birth

  Rate of live birth at or beyond 20 completed weeks' gestation

  At or beyond 20 completed weeks' gestation

Secondary Outcomes (18)

• Pregnancy outcome: Ongoing pregnancy

  Beyond 12 weeks' gestation

• Pregnancy outcome: Miscarriage during the first trimester

  During the first trimester (at or before 12 weeks' gestation)

• Pregnancy outcome: Miscarriage during second and third trimesters

  During second and third trimesters (beyond 12 weeks' gestation until 20 weeks)

• Pregnancy outcome: Termination

  At any time during treatment (up to 2 months) and follow-up period (up to 1 year)

• Pregnancy outcome: Stillbirth

  At or beyond 20 weeks' gestation

Other Outcomes (29)

• Safety outcomes: Serious adverse events - Acute kidney injury (AKI)

  At any time during treatment (up to 2 months) and follow-up period (up to 1 year)

• Safety outcomes: Serious adverse events - Drug induced liver injury (DILI)

  At any time during treatment (up to 2 months) and follow-up period (up to 1 year)

• Safety outcomes: Serious adverse events - Hospitalization

  At any time during treatment (up to 2 months) and follow-up period (up to 1 year)

Study Arms (4)

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).

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).

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).

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).

Drug: Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral Progesterone Placebo

Interventions

Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone Placebo DRUG

Chinese Herbal Medicine (New "Shoutai Wan", one pack twice daily) + Oral Progesterone Placebo (100 mg thrice daily)

NSTW + OP placebo

Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral Progesterone DRUG

Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo, one pack twice daily) + Oral Progesterone (100 mg thrice daily)

NSTW Placebo + OP

Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral Progesterone Placebo DRUG

Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo, one pack twice daily) + Oral Progesterone Placebo (100 mg thrice daily)

NSTW Placebo + OP Placebo

Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone DRUG

Chinese Herbal Medicine (New "Shoutai Wan", one pack twice daily) + Oral Progesterone (100 mg thrice daily)

NSTW + OP

Eligibility Criteria

• Age: 20 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Known current or recent alcohol abuse or illicit drug use.
• Known abnormal parental karyotype.
• Unwilling to give informed consent.

Sponsors & Collaborators

• Heilongjiang University of Chinese Medicine: lead

Study Sites (22)

The First Affiliated Hospital of Anhui University of Chinese Medicine

Hefei, Anhui, China

Location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Location

Da Qing Long Nan Hospital

Daqing, Heilongjiang, China

Location

First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Location

Luoyang Hospital of Traditional Chinese Medicine

Luoyang, Henan, China

Location

The First Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, China

Location

Changzhou Hospital of Traditional Chinese Medicine

Changzhou, Jiangsu, China

Location

Suqian Maternity Hospital

Suqian, Jiangsu, China

Location

The People's Hospital of Siyang

Suqian, Jiangsu, China

Location

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Location

Xuzhou Maternal and Child Health Hospital

Xuzhou, Jiangsu, China

Location

Jiangxi Maternity and Child Health Hospital

Nanchang, Jiangxi, China

Location

The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, China

Location

Dalian Maternal and Child Health Hospital

Dalian, Liaoning, China

Location

Dalian women and children's medical group

Dalian, Liaoning, China

Location

The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

Location

Ningxia Chinese Medicine Research Center

Yinchuan, Ningxia, China

Location

Taian City Central Hospital

Tai’an, Shandong, China

Location

Shanxi Traditional Chinese Medical Hospital

Taiyuan, Shanxi, China

Location

Hangzhou Hospital of Traditional Chinese Medicine

Hangzhou, Zhejiang, China

Location

Wenzhou TCM Hospital of Zhejiang Chinese Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Abortion, Threatened

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Xiao-Ke Wu, Ph.D

  First Affiliated Hospital of Heilongjiang Chinese Medicine University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Obstetrics and Gynecology Department

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 17, 2015
• Study Start: October 20, 2017
• Primary Completion: October 26, 2025
• Study Completion: December 31, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (22)