Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla

Phase 4

• Conditions: Thrombophilia With Recurrent Pregnancy Loss
• Interventions: Drug: Aspirin; Drug: Heparin

• Registration Number: NCT02986594
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-27
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-08
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-09
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aspirin group	Aspirin	low dose aspirin, 75-100mg, bid, after pregnancy
combination group	Aspirin	low molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy
low molecular weight heparin group	Heparin	low molecular weight heparin, 4100u, qd, after pregnancy
combination group	Heparin	low molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy

Primary Outcome Measures

Name	Time	Method
D-Dimer	through study completion, an average of 3 year

Secondary Outcome Measures

Name	Time	Method
BMI in kg/m^2	through study completion, an average of 3 year

Trial Locations

Locations (1)

Shanghai first Maternity and Infant health hospital, Tong Ji University; 🇨🇳 Shanghai, China