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Clinical observation of SiShenWan in the treatment of unexplained recurrent miscarriage and study of its effect ondecidual immune cells in the maternal-fetal interface microenvironment

Clinical observation of SiShenWan in the treatment of unexplained recurrent miscarriage and study of its effect ondecidual immune cells in the maternal-fetal interface microenvironment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025000381
Enrollment
Unknown
Registered
2025-02-21
Start date
2025-02-23
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Unexplained Recurrent Spontaneous Abortion

Interventions

SiShenWan:The medical record shows that during this pregnancy the patient received SishenWan (continuously taken for = 2 weeks) which can be combined with routine Western medicine treatment for fetal
Control:Patients who did not receive Sishen Pill treatment

Sponsors

The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of unexplained recurrent miscarriage (URSA): natural miscarriage = 2 or = 3 times excluding known causes such as immunity genetics anatomy endocrinology and infection; 2. Age between 18 and 45 years old with complete outpatient or inpatient medical records available for review; 3. Have received fetal protection treatment in our hospital and have clear records of whether to use the "Si Shen Wan"; 4. The pregnancy outcome data in the medical record is complete and can be traced back to pregnancy up to 12 weeks and above or perinatal outcomes.

Exclusion criteria

Exclusion criteria: 1. Discovering obvious causes or serious organic diseases (tumors severe liver liver and kidney dysfunction etc.); 2. The data is severely missing making it impossible to confirm the pregnancy outcome or medication use; 3. During pregnancy other traditional Chinese medicine formulas were used but it was not possible to distinguish whether they included Si Shen Wan; 4. The combination of other special medications during pregnancy may significantly affect the results (such as high-dose hormones immunosuppressants etc.) and the effects cannot be distinguished.

Design outcomes

Primary

MeasureTime frame
Successful pregnancy rate;Live birth rate (the proportion of live infants delivered at or near full term);

Secondary

MeasureTime frame
Recurrent miscarriage rate (miscarriage situation at this time or follow-up);Pregnancy complications (pregnancy hypertension diabetes etc.);Newborn condition (birth weight Apgar score if recorded);

Countries

China

Contacts

Public ContactZhouXuan

The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

chowxuanhk@gmail.com18255127140

Outcome results

None listed

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