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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03735108
Other study ID # ShanghaiFMIH Shihua Bao
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date June 30, 2019

Study information

Verified date October 2018
Source Shanghai First Maternity and Infant Hospital
Contact Shihua Bao
Phone 86-021-20261599
Email baoshihua@tongji.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. Establish a multi-platform detection system for neutrophil extracellular traps in blood and tissues, and evaluate the detection performance;

2. Comparing the expression levels of neutrophil extracellular traps in peripheral blood and decidua of patients with antiphospholipid antibody-induced pregnancy loss and normal control group;

3. Comparing the expression levels of neutrophil extracellular traps in peripheral blood and decidua of mice with antiphospholipid antibody-induced pregnancy loss and normal control group;

4. After treatment of antiphospholipid antibody-induced mouse abortion model with metformin,the effect of metformin on embryo loss rate and viable embryo body weight was observed.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 41 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of Recurrent spontaneous abortion

- Clinical diagnosis of Antiphospholipid syndrome

Exclusion Criteria:

- Other autoimmune diseases

- Hematopoietic system diseases

- Cardiovascular system diseases

- Gastrointestinal system diseases

- Urinary system diseases

- Nervous system or mental diseases

- Have taken other drugs recently

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Shanghai First Maternity and Infant Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other C3 level Complement component 3, often simply called C3, is a protein of the immune system. It plays a central role in the complement system and contributes to innate immunity. through study completion, an average of 8 months
Primary NETs level Neutrophil extracellular traps (NETs) are networks of extracellular fibers, primarily composed of DNA from neutrophils, which bind pathogens. through study completion, an average of 8 months
Secondary complete blood count (CBC) CBC is a blood panel requested by a doctor or other medical professional that gives information about the cells in a patient's blood, such as the cell count for each blood cell type and the concentrations of hemoglobin. through study completion, an average of 8 months