Skip to content

Effect of Zhuyun Pills combined with dydrogesterone on early pregnancy outcome in threatened abortion: a multicenter randomized controlled trial

Effect of Zhuyun Pills combined with dydrogesterone on early pregnancy outcome in threatened abortion: a multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026427
Enrollment
Unknown
Registered
2019-10-09
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Threatened abortion

Interventions

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) Age between 25 and 40 years. We exclude older women because because older women are known to have a high risk of aneuploidy abnormal embryos and abnormal genes. (2) positive urine pregnancy test or blood HCG test. (3) Early pregnancy (5-10 weeks/35-70 days) Vaginal bleeding, cervix closure, with or without abdominal pain, ultrasound diagnosis of intrauterine embryo or fetus survival. (4) The threatened abortion was not treated. (5) The subject and her spouse are capable and willing to sign informed consent. (6) Subject to randomization and medication as prescribed by the study protocol until 12 weeks of gestation (84 days).

Exclusion criteria

Exclusion criteria: (1) Multiple pregnancy (including twins). (2) Recurrent abortion (spontaneous abortion >= 3 times, including biochemical abortion and intrauterine abortion after 6 weeks of last menstruation). (3) Ectopic pregnancy (non-intrauterine pregnancy with suspected accessory mass or large amount of pelvic free fluid in non-intrauterine pregnancy). (4) pregnancy at unknown locations, including HCG level higher than 2500 mIU/ml but no intrauterine or extrauterine pregnancy. (5) Abnormal uterine anatomy and submucosal uterine fibroids (evaluated by ultrasound). (6) Vaginal bleeding from the vulva, vagina or cervix that is not related to pregnancy. (7) Chinese medicine has been taken in the last two months. (8) Taking progesterone (oral, intramuscular, vaginal, etc.) in the last two months. (9) Used drugs that cause bleeding, such as non-steroidal anti-inflammatory drugs aspirin. (10) Congenital or acquired bleeding tendency (hemophilia, von Willebrand disease or use of anticoagulants, etc.). (11) Suffering from major illnesses (regardless of severity), including poorly controlled diabetes, uncontrolled hypertension, systemic lupus erythematosus, untreated or active cancer (excluding any cancer in remission or non-melanoma skin cancer), liver disease, kidney disease, rheumatoid arthritis, heart disease, lung disease other than mild asthma, need medication of nervous system disease, uncontrolled hypothyroidism, uncontrolled epilepsy, Untreated vitamin B12 deficiency, severe anemia (hematocrit < 30%), gout or nasal polyps. (12) Known current/recent history of alcohol abuse or taking illegal drugs. (13) Known parental karyotype abnormalities.

Design outcomes

Primary

MeasureTime frame
Early pregnancy embryo survival rate;

Secondary

MeasureTime frame
Blood ß-hCG;progesterone;Estradiol;Complete Blood Count;Urine Routine;Hepatic Function Test;Renal function test;

Countries

China

Contacts

Public ContactLuo Songping

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

gjfkts@qq.com+86 13760605046

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026