Neutrophil Extracellular Traps Mediate Antiphospholipid Antibody-induced Pregnancy Loss

November 7, 2018 updated by: Shihua Bao, Shanghai First Maternity and Infant Hospital
  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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai first maternity and infant hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

City

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
pregnancy loss group
the times of pregnancy loss more than or equal to twice
normal control group
no history of pregnancy loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NETs level
Time Frame: 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.
through study completion, an average of 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete blood count (CBC)
Time Frame: 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.
through study completion, an average of 8 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
C3 level
Time Frame: 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.
through study completion, an average of 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai First Maternity and Infant Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 7, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiFMIH Shihua Bao

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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