Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla

Thrombophilia With Recurrent Pregnancy Loss Clinical Trial

Official title:

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02986594
• Other study ID #: ShanghaiFIMH-0002
• Status: Recruiting
• Phase: Phase 4
• First received: November 27, 2016
• Last updated: December 8, 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: Interventional

Clinical Trial Summary

In this clinical cohort study, the investigators observe the efficacy of low molecular weight heparin in the treatment of thrombophilia with recurrent pregnancy loss with a prospective randomized controlled trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Woman who had their Second miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form.

Exclusion Criteria:

1. having experiencedsevere 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 rotine)

8. Chromosome aberrations in anyone of the couple.

9. patients who have drug contraindications

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thrombophilia
• Thrombophilia With Recurrent Pregnancy Loss

Intervention

Drug:
• Aspirin

• Heparin

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