Clinical Trial: Chinese Herbal Medicine and Micronized Progesterone for Threatened Miscarriage RCT

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title:

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.Micronized progesterone which is used in a range of indications including infertility due to luteal insufficiency and threatened and habitual abortion, has a similar molecular structure and pharmacological effects to endogenous progesterone.Chinese Herbal Medicines is a part of Traditional Chinese Medicines and has been widely used for the treatment of miscarriage in China and other Asian countries for centuries.CHM have become very popular alternative to Western medicines and are commonly used as an alternative treatment for threatened miscarriage.Amongst all the causes for threatened miscarriage, "Kidney Deficiency" is the most important cause leading to threatened miscarriage and "Shou Tai Pill" is the most frequently used formula (72.0%) to treat threatened miscarriage.This basic formula is made up of four individual Chinese medicines, including Chinese Dodder Seed (Semen Cuscuta), Chinese Taxillus Twig (Flerlia Taxillus), Himalayan Teasel Root (Radix Dipsaci), and Donkey-hide Glue (Colla Corii Asini).Furthermore, supplementary of Common/Wingde Yan Rhizoma in the formula can enhance the therapeutic effects by further strengthening kidney of pregnant women.The goal of this double-bind, randomized and double dummy controlled trial is to determine which of the two oral medications, CHM or Micronized progesterone, and will mostly likely result in live birth in women with threatened miscarriage.

Detailed Summary:
Sponsor: Heilongjiang University of Chinese Medicine

Current Primary Outcome: Live birth rate [ Time Frame: Up to 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ongoing pregnancy rate（Beyond gestation 12 weeks） [ Time Frame: Up to 1 years ]
  • Ongoing pregnancy rate(Beyond gestation 20 weeks) [ Time Frame: Up to 1 years ]
  • Ongoing pregnancy rate(Beyond gestation 32 weeks) [ Time Frame: Up to 1 years ]
  • Live births [ Time Frame: Up to 1 years ]
    >37 weeks of gestation
  • Premature live births [ Time Frame: Up to 1 years ]
    > 24, but <37 weeks of gestation
  • anti ovarian antibody [ Time Frame: Up to 1 years ]
    The number of anti ovarian antibody positive patients
  • antisperm antibody [ Time Frame: Up to 1 years ]
    The number of antisperm antibody positive patients
  • anticardiolipin antibody [ Time Frame: Up to 1 years ]
    The number of anticardiolipin antibody positive patients
  • anti uterus endometrial antibody [ Time Frame: Up to 1 years ]
    The number of anti uterus endometrial antibody positive patients
  • antinuclear antibody [ Time Frame: Up to 1 years ]
    The number of antinuclear antibody positive patients
  • Resistive Index of ovary [ Time Frame: Up to 1 years ]
    By ultrasound
  • Resistive Index of uteru [ Time Frame: Up to 1 years ]
    By ultrasound
  • Pulsatility Index of ovary [ Time Frame: Up to 1 years ]
    By ultrasound
  • Pulsatility Index of uteru [ Time Frame: Up to 1 years ]
    By ultrasound
  • Biochemical pregnancy loss rate [ Time Frame: Up to 1 years ]
    Defined as positive result of HCG test with invisible gestational sac and fetal heart
  • Pregnancy loss rate [ Time Frame: Before 20 weeks of gestation ]
    Number of patients who have a pregnancy loss before 20 weeks of gestation
  • Pregnancy loss rate [ Time Frame: After 20 weeks of gestation ]
    Number of patients who have a pregnancy loss after 20 weeks of gestation
  • Serum Progesterone Level [ Time Frame: Up to 1 years ]
    Units: ng/ml
  • Pregnancy-induced hypertension [ Time Frame: Up to 1 years ]
  • Diabetes [ Time Frame: Up to 1 years ]
    The number of participants with diabetes
  • Antepartum haemorrhage [ Time Frame: Up to 1 years ]
    The number of participants with antepartum haemorrhage
  • Preterm birth [ Time Frame: Up to 1 years ]
    Preterm birth rate
  • Postdate delivery [ Time Frame: Up to 1 years ]
    Postdate delivery rate
  • Preeclampsia [ Time Frame: Up to 1 years ]
    The number of participants with Preeclampsia
  • Intrauterine Growth Retardation [ Time Frame: Up to 1 years ]
    Intrauterine Growth Retardation Rate
  • Small for gestational age infant [ Time Frame: Up to 1 years ]
    The number of small for gestational age infant
  • Stillbirth [ Time Frame: Up to 1 years ]
    Stillbirth rate
  • Neonatal death [ Time Frame: Up to 1 years ]
  • Congenital anomaly [ Time Frame: Up to 1 years ]
    Fetal complication
  • Birth defect rates [ Time Frame: Up to 1 years ]
    Fetal complication
  • Zung Self-Rating Anxiety Scale [ Time Frame: Up to 1 years ]
  • Zung Self-Rating Depression Scale [ Time Frame: Up to 1 years ]


Original Secondary Outcome:

  • Serum Progesterone [ Time Frame: Up to 1 years ]
    Serum Progesterone Level
  • anti ovarian antibody [ Time Frame: Up to 1 years ]
  • antisperm antibody [ Time Frame: Up to 1 years ]
  • anticardiolipin antibody [ Time Frame: Up to 1 years ]
  • anti uterus endometrial antibody [ Time Frame: Up to 1 years ]
  • antinuclear antibody [ Time Frame: Up to 1 years ]
  • Resistive Index of ovary and uterus [ Time Frame: Up to 1 years ]
    By ultrasound
  • Pulsatility Index of ovary and uterus [ Time Frame: Up to 1 years ]
    By ultrasound
  • Early pregnancy loss [ Time Frame: Up to 1 years ]
    Defined as biochemical pregnancy losses
  • Early intrauterine pregnancy losses [ Time Frame: Up to 1 years ]
    Before 20 completed weeks of gestation
  • Later intrauterine pregnancy losses [ Time Frame: Up to 1 years ]
    After 20 completed weeks of gestation
  • Ongoing pregnancy rate（Beyond gestation 12 weeks） [ Time Frame: Up to 1 years ]
  • Ongoing pregnancy rate(Beyond gestation 20 weeks) [ Time Frame: Up to 1 years ]
  • Ongoing pregnancy rate(Beyond gestation 32 weeks) [ Time Frame: Up to 1 years ]
  • Live births [ Time Frame: Up to 1 years ]
    >37 weeks of gestation
  • Premature live births [ Time Frame: Up to 1 years ]
    > 24, but <37 weeks of gestation
  • Pregnancy-induced hypertension [ Time Frame: Up to 1 years ]
  • Diabetes [ Time Frame: Up to 1 years ]
    The number of participants with diabetes
  • Antepartum haemorrhage [ Time Frame: Up to 1 years ]
    The number of participants with antepartum haemorrhage
  • Preterm birth [ Time Frame: Up to 1 years ]
    Preterm birth rate
  • Postdate delivery [ Time Frame: Up to 1 years ]
    Postdate delivery rate
  • Preeclampsia [ Time Frame: Up to 1 years ]
    The number of participants with Preeclampsia
  • Intrauterine Growth Retardation [ Time Frame: Up to 1 years ]
    Intrauterine Growth Retardation Rate
  • Small for gestational age infant [ Time Frame: Up to 1 years ]
    The number of small for gestational age infant
  • Stillbirth [ Time Frame: Up to 1 years ]
    Stillbirth rate
  • Neonatal death [ Time Frame: Up to 1 years ]
  • Congenital anomaly [ Time Frame: Up to 1 years ]
    Fetal complication
  • Birth defect rates [ Time Frame: Up to 1 years ]
    Fetal complication
  • Zung Self-Rating Anxiety Scale [ Time Frame: Up to 1 years ]
  • Zung Self-Rating Depression Scale [ Time Frame: Up to 1 years ]


Information By: Heilongjiang University of Chinese Medicine

Dates:
Date Received: December 7, 2015
Date Started: December 2015
Date Completion:
Last Updated: December 20, 2015
Last Verified: December 2015