Chinese Herbal Medicine and Micronized Progesterone for Live Births in Threatened Miscarriage

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

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 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. We will evaluate the efficacy and safety of CHM and micronized progesterone for treating threatened miscarriage in this trial. Our primary outcome of this trial is a live birth. We hypothesize that: 1. treatment with CHM plus micronized progesterone placebo or micronized progesterone plus CHM placebo or CHM plus Micronized progesterone is more likely to result in live birth than the control arm which will be CHM placebo plus micronized progesterone placebo; 2. CHM plus micronized progesterone placebo and micronized progesterone plus CHM placebo will have similar treatment effects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heilongjiang University of Chinese Medicine
• Treatments: Progesterone

Criteria

Inclusion criteria

1. Age of women between 20-37 years.

2. Pregnant. The fetus is viable inside the uterine cavity during early pregnancy[1] (5-10 week gestations /35-70 days) as confirmed by positive serum hCG tests and ultrasound, and need to meet either of the following two terms: ① vaginal bleeding with or without abdominal pain, while the cervix is closed by speculum exam; ②Recurrent miscarriage (≥2 prior pregnancy losses including biochemical pregnancy and intrauterine pregnancy loss or a pregnancy loss ≥ 6 weeks from LMP).

Exclusion criteria

1. Multiple pregnancies (include twin 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. 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.

4. (4)Non-viable pregnancy. We will define a non-viable pregnancy as: ①an intrauterine pregnancy with a fetal pole without visualized fetal heart motion (>49 days); ②a gestational sac>20 mm in any diameter without a yolk sac; ③absence 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; ④falling 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%).

5. Intrauterine abnormalities and Fibroids distorting uterine cavity (as assessed by ultrasound).

6. Bleeding attributed to a vulvar, vaginal, or cervical source unrelated to the pregnancy.

7. For this threatened miscarriage, use of the same or similar Chinese medicine and/or progesterone more than one week.

8. Use of agents that may contribute to bleeding such as aspirin, NSAIDs, etc.

9. Presence of a congenital or acquired bleeding diathesis, i.e. Hemophilia, Von Willebrands's Disease, use of anti-coagulants, etc.

10. 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.

11. Known current or recent alcohol abuse or illicit drug use.

12. Known abnormal parental karyotype.

13. Unwilling to give informed consent.

14. Unwillingness to be randomized and do not want to take daily medications according to the protocol for up to 12 week gestations (84 days).