The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss

Study Overview
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Brief Summary
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In this clinical cohort study, the investigators are going to observe the efficacy of anti-coagulation and immune therapy in the treatment of recurrent pregnancy loss with a prospective randomized controlled trial.

Official Title
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The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss

Conditions
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Recurrent Pregnancy Loss

Intervention / Treatment
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* Drug: Aspirin
* Drug: Heparin
* Drug: Prednisone
* Drug: Immunoglobulin
* Drug: Dydrogesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Woman who had 2 miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form. Exclusion Criteria: 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. 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. patients who have drugs contraindications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aspirin+LMWH group<br>aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd | Drug: Aspirin<br> <br> Drug: Heparin<br> <br> |
| Experimental: aspirin+LMWH+immunoglobulin group<br>aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks | Drug: Aspirin<br> <br> Drug: Heparin<br> <br> Drug: Immunoglobulin<br> <br> |
| Experimental: aspirin+LMWH+prednisone group<br>aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd | Drug: Aspirin<br> <br> Drug: Heparin<br> <br> Drug: Prednisone<br> <br> |
| Experimental: aspirin+LMWH+IVIG+prednisone group<br>aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd | Drug: Aspirin<br> <br> Drug: Heparin<br> <br> Drug: Prednisone<br> <br> Drug: Immunoglobulin<br> <br> |
| Other: dydrogesterone group<br>dydrogesterone 20-30mg/day, po, tid | Drug: Dydrogesterone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth | live birth means success pregnancy（more than gestational age of 20 weeks） | through study completion, an average of 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| D-dimer |  | through study completion, an average of 3 year | 
| Uterine artery blood flow |  | through study completion, an average of 3 year | 
| human chorionic gonadotropin |  | through study completion, an average of 3 year |