Neutrophil Extracellular Traps Mediate Antiphospholipid Antibody-induced Pregnancy Loss

• Sponsor: Shanghai First Maternity and Infant Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03735108
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 7.9
• Patients Per Site Per Month: 12.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neutrophil Extracellular Traps; Antiphospholipid Antibody-induced Pregnancy Loss

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Neutrophil Extracellular Traps Mediate Antiphospholipid Antibody-induced Pregnancy Loss
• Actual Study Start Date: Nov 1, 2018
• Anticipated Primary Completion Date: Jun 30, 2019
• Anticipated Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
pregnancy loss group the times of pregnancy loss more than or equal to twice
normal control group no history of pregnancy loss

Outcome Measures

Primary Outcome Measures

1. NETs level [through study completion, an average of 8 months]

   Neutrophil extracellular traps (NETs) are networks of extracellular fibers, primarily composed of DNA from neutrophils, which bind pathogens.

Secondary Outcome Measures

1. complete blood count (CBC) [through study completion, an average of 8 months]

   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.

Other Outcome Measures

1. C3 level [through study completion, an average of 8 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 41 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai First Maternity and Infant Hospital	Shanghai		China

Sponsors and Collaborators

• Shanghai First Maternity and Infant Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shihua Bao, Associate Professor, Shanghai First Maternity and Infant Hospital
• ClinicalTrials.gov Identifier: NCT03735108
• Other Study ID Numbers: ShanghaiFMIH Shihua Bao
• First Posted: Nov 8, 2018
• Last Update Posted: Nov 8, 2018
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Abortion, Spontaneous; Fetal Death

Study Results

No Results Posted as of Nov 8, 2018