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The Epidemiology of Recurrent Spontaneous Abortion Associated With Thrombophilla

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ClinicalTrials.gov Identifier: NCT02990390
Recruitment Status : Unknown
Verified November 2016 by Shihua Bao, Shanghai First Maternity and Infant Hospital.
Recruitment status was:  Recruiting
First Posted : December 13, 2016
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Shihua Bao, Shanghai First Maternity and Infant Hospital

Brief Summary:
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.

Condition or disease
Recurrent Pregnancy Loss

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Study Type : Observational
Estimated Enrollment : 45000 participants
Observational Model: Cohort
Official Title: Shanghai First Maternity and Infant Hospital
Study Start Date : November 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019



Primary Outcome Measures :
  1. D-Dimer [ Time Frame: through study completion, an average of 3 year ]

Secondary Outcome Measures :
  1. BMI in kg/m^2 [ Time Frame: through study completion, an average of 3 year ]
  2. platelet aggregation time [ Time Frame: through study completion, an average of 3 year ]
  3. anticardiolipin antibody [ Time Frame: through study completion, an average of 3 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Woman who had their Second miscarriage before 12(th) week of gestation.
Criteria

Inclusion Criteria:

  • Woman who had 2 miscarriages before 12(th) week of gestation.Signed consent form.

Exclusion Criteria:

  1. having experienced severe allergies, trauma history and/or operation history within 3 months;
  2. with a history of mental illness and/or family history of mental illness
  3. limb disabled
  4. taking medicine within one month
  5. suffering major events or having mood swings
  6. with a history of recurrent pregnancy loss
  7. having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)
  8. chromosome aberrations in anyone of the couple.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990390


Locations
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China
Shanghai first Maternity and Infant health hospital, Tong Ji University Recruiting
Shanghai, China, 200051
Contact: Shihua Bao, PhD    86-21-20261430 ext 2012    baoshihua@tongji.edu.cn   
Contact: Yan Yan, Master    86-21-20261430 ext 2012    shtjyanyan@163.com   
Principal Investigator: Shihua Chen, PhD         
Sub-Investigator: Yan Yan, master         
Sponsors and Collaborators
Shanghai First Maternity and Infant Hospital
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Responsible Party: Shihua Bao, Principal Investigator, Shanghai First Maternity and Infant Hospital
ClinicalTrials.gov Identifier: NCT02990390    
Other Study ID Numbers: ShanghaiFMIH-0001
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided