The Epidemiology of Recurrent Spontaneous Abortion Associated With Thrombophilla

NCT02990390 | Unknown DMC

• 1 other identifier: ShanghaiFMIH-0001
• Study Type: observational
• Target: 45,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

• D-Dimer

  through study completion, an average of 3 year

Secondary Outcomes (3)

• BMI in kg/m^2

  through study completion, an average of 3 year

• platelet aggregation time

  through study completion, an average of 3 year

• anticardiolipin antibody

  through study completion, an average of 3 year

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Woman who had their Second miscarriage before 12(th) week of gestation.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

Study Sites (1)

Shanghai first Maternity and Infant health hospital, Tong Ji University

Shanghai, 200051, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: December 13, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 14, 2016

Record last verified: 2016-11

Locations

CN (1)