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

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

Interventions

DRUG

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

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

DRUG

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

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

DRUG

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

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

DRUG

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

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

Sponsors & Collaborators

• Heilongjiang University of Chinese Medicine

  lead OTHER

Principal Investigators

• Xiao-Ke Wu, Ph.D · First Affiliated Hospital of Heilongjiang Chinese Medicine University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

20 Years

Max Age

37 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-20

Primary Completion

2025-10-26

Completion

2025-12-31

Countries

• China

Study Locations