- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02990390
The Epidemiology of Recurrent Spontaneous Abortion Associated With Thrombophilla
December 13, 2016 updated by: Shihua Bao, Shanghai First Maternity and Infant Hospital
Shanghai First Maternity and Infant Hospital
RSA is a multifactorial disorder resulting from genetic factors, anatomic factors, autoimmune disorders, endocrine dysfunction, thrombophilia, life style factors, and maternal infections.
However, the underlying causes remain undetermined in up to 50% of cases.
In this clinical cohort study, we intended to get an epidemiological evidence for patients with recurrent spontaneous abortion associated with thrombophilla.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
45000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China, 200051
- Recruiting
- Shanghai first Maternity and Infant health hospital, Tong Ji University
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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
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Woman who had their Second miscarriage before 12(th) week of gestation.
Description
Inclusion Criteria:
- Woman who had 2 miscarriages before 12(th) week of gestation.Signed consent form.
Exclusion Criteria:
- having experienced severe allergies, trauma history and/or operation history within 3 months;
- with a history of mental illness and/or family history of mental illness
- limb disabled
- taking medicine within one month
- suffering major events or having mood swings
- with a history of recurrent pregnancy loss
- having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)
- chromosome aberrations in anyone of the couple.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
D-Dimer
Time Frame: through study completion, an average of 3 year
|
through study completion, an average of 3 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BMI in kg/m^2
Time Frame: through study completion, an average of 3 year
|
through study completion, an average of 3 year
|
platelet aggregation time
Time Frame: through study completion, an average of 3 year
|
through study completion, an average of 3 year
|
anticardiolipin antibody
Time Frame: through study completion, an average of 3 year
|
through study completion, an average of 3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
November 1, 2016
Primary Completion (Anticipated)
October 1, 2019
Study Completion (Anticipated)
October 1, 2019
Study Registration Dates
First Submitted
November 27, 2016
First Submitted That Met QC Criteria
December 8, 2016
First Posted (Estimate)
December 13, 2016
Study Record Updates
Last Update Posted (Estimate)
December 14, 2016
Last Update Submitted That Met QC Criteria
December 13, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ShanghaiFMIH-0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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