Neutrophil Extracellular Traps; Antiphospholipid Antibody-induced Pregnancy LossNCT03735108
Neutrophil Extracellular Traps Mediate Antiphospholipid Antibody-induced Pregnancy Loss
An observational study of Neutrophil Extracellular Traps; Antiphospholipid Antibody-induced Pregnancy Loss, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 25 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neutrophil Extracellular Traps; Antiphospholipid Antibody-induced Pregnancy Loss
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: City
Who may be able to join
- Clinical diagnosis of Recurrent spontaneous abortion
- Clinical diagnosis of Antiphospholipid syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai First Maternity and Infant Hospital
Shanghai
Shihua Bao, 86-021-20261599, baoshihua@tongji.edu.cn
About this study
- Establish a multi-platform detection system for neutrophil extracellular traps in blood and tissues, and evaluate the detection performance;
- 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;
- 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;
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pregnancy loss group | the times of pregnancy loss more than or equal to twice | |
| normal control group | no history of pregnancy loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
NETs level
Neutrophil extracellular traps (NETs) are networks of extracellular fibers, primarily composed of DNA from neutrophils, which bind pathogens.
Measured: through study completion, an average of 8 months
Secondary outcomes (1)
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.
Measured: through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Nov 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutrophil Extracellular Traps; Antiphospholipid Antibody-induced Pregnancy LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shihua Bao, Shanghai First Maternity and Infant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735108
- Sponsor's protocol ID
- ShanghaiFMIH Shihua Bao
- Status last verified
- Oct 2018
- First submitted
- 1 Nov 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil Extracellular Traps Mediate Antiphospholipid Antibody-induced Pregnancy Loss
- ClinicalTrials.gov ID
- NCT03735108
- Acronym / sponsor ID
- ShanghaiFMIH Shihua Bao
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Establish a multi-platform detection system for neutrophil extracellular traps in blood and tissues, and evaluate the detection performance;
- 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;
- 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;
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnancy loss group | – | –the times of pregnancy loss more than or equal to twice |
| normal control group | – | –no history of pregnancy loss |
Who may qualify
- Ages
- 25 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- City
Key inclusion criteria (2 listed)
- Clinical diagnosis of Recurrent spontaneous abortion
- Clinical diagnosis of Antiphospholipid syndrome
Key exclusion criteria (7 listed)
- Other autoimmune diseases
- Hematopoietic system diseases
- Cardiovascular system diseases
- Gastrointestinal system diseases
- Urinary system diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
complete blood count (CBC)
Time frame: through study completion, an average of 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neutrophil Extracellular Traps; Antiphospholipid Antibody-induced Pregnancy Loss, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shihua Bao (86-021-20261599, baoshihua@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NETs level (time frame: through study completion, an average of 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.