threatened miscarriage
Conditions
Interventions
A: CHM+ Micronized Progesterone Placebo
B: CHM Placebo+ Micronized Progesterone
C: CHM+ Micronized Progesterone
D: CHM Placebo+ Micronized Progesterone Placebo
Sponsors
Heilongjiang University of Chinese Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Women aged 18 to37 years. We will exclude older women because of the known greater risk of aneuploidy and genetic abnormalities in abnormal conceptuses of older women; (2) Pregnant (as confirmed by positive urinary pregnancy tests); (3) Vaginal bleeding with or without abdominal pain, while the cervix is closed by visual exam and the fetus is viable inside the uterine cavity during early pregnancy [1]. (5-10 weeks gestation); (4) No previous treatment for miscarriage; (5) To be able to and willing to give informed consent; (6) Willing to be allocated randomly and to take daily study medications for up to several months.
Exclusion criteria
Exclusion criteria: (1) 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; (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) Multiple pregnancy; (4) > 2 prior pregnancy losses including biochemical pregnancy and intrauterine pregnancy loss or a pregnancy loss >=6 weeks from LMP; (5) Non-viable pregnancy. We will define a non-viable pregnancy as an intrauterine pregnancy with a fetal pole without visualized fetal heart motion or a gestational sac > 20 mm in any diameter without a yolk sac or falling serum hCG values on serial visits or between baseline and randomization visit. (Or define by this: absence of a normal gestational sac at 5 weeks of pregnancy, a yolk sac at 5.5–6 weeks of pregnancy, an embryo at 6–6.5 weeks of pregnancy or cardiac activity at 7 weeks of pregnancy by ultrasound); (6) Serial serum hCG levels which show a decline or a plateau (2 day increase <=10%); (7) Intrauterine abnormalities and Fibroids distorting uterine cavity (as assessed by ultrasound); (8) Known abnormal parental karyotype; (9) Bleeding attributed to a vulvar, vaginal, or cervical source unrelated to the pregnancy; (10) Presence of a congenital or acquired bleeding diathesis, i.e. Hemophilia, Von Willebrandss Disease, use of anti-coagulants, etc.; (11) 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, among others; (12) Use of agents that may contribute to bleeding such as aspirin, NSAIDs, etc.; (13) Current use of Chinese Herbal Medicines within 2 months; (14) Current use of progestins- oral, intramuscular, vaginal, etc within 2 months; (15) Known current or recent alcohol abuse or illicit drug use; (16) Current diagnosis of sexually transmitted infection (STI) (temporary exclusion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progesterone;anti-ovarian antibody;antisperm antibody;anticardiolipin antibody;anti uterus endometrial antibody;antinuclear antibody;resistive Index of ovary and uterus;Pulsatility Index of ovary and uterus;Early pregnancy loss;loss of an intrauterine pregnancy before 20 completed weeks of gestation;Later Intrauterine Pregnancy losses after 20 completed weeks of gestation;Ongoing pregnancy rate: beyond gestation 12 weeks;Ongoing pregnancy rate: beyond gestation 20 weeks;Ongoing pregnancy rate: beyond gestation 32 weeks;live births (>37 weeks of gestation);premature live births (> 24, but <37 weeks of gestation);Maternal Complications: Pregnancy-induced hypertension;Maternal Complications: diabetes;Maternal Complications:antepartum haemorrhage;Maternal Complications:preterm birth;Maternal Complications:postdate delivery;Maternal Complications:preeclampsia;Fetal Complications:abnormal fetal testing;Fetal Complications:IUGR;Fetal Complications:Small for gestational age infant;Fetal Complications:Stillbirth;Fetal Complications:Neonatal death;Fetal Complications:Congen Fetal Complications;Change in QOL;Change in symptoms of anxiety and depression;Change in symptoms of TCM;Pain relief;Side effect profile; | — |
Countries
CHINA
Contacts
Public ContactXiaoke Wu
Outcome results
None listed