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

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

      • Shanghai, China, 200051
        • Recruiting
        • Shanghai first Maternity and Infant health hospital, Tong Ji University

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:

  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.

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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