The Epidemiology of Recurrent Spontaneous Abortion Associated With Thrombophilla

Recurrent Pregnancy Loss Clinical Trial

Official title:

Shanghai First Maternity and Infant Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02990390
• Other study ID #: ShanghaiFMIH-0001
• Status: Recruiting
• Phase: N/A
• First received: November 27, 2016
• Last updated: December 13, 2016
• Start date: November 2016
• Est. completion date: October 2019

Study information

• Verified date: November 2016
• Source: Shanghai First Maternity and Infant Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45000
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Recurrent Pregnancy Loss

Locations

Country	Name	City	State
China	Shanghai first Maternity and Infant health hospital, Tong Ji University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	D-Dimer		through study completion, an average of 3 year	Yes
Secondary	BMI in kg/m^2		through study completion, an average of 3 year	Yes
Secondary	platelet aggregation time		through study completion, an average of 3 year	Yes
Secondary	anticardiolipin antibody		through study completion, an average of 3 year	Yes