The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss
Overview
- Phase
- Phase 4
- Intervention
- Aspirin
- Conditions
- Recurrent Pregnancy Loss
- Sponsor
- Shanghai First Maternity and Infant Hospital
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- live birth
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Shihua Bao
Principal Investigator
Shanghai First Maternity and Infant Hospital
Eligibility Criteria
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
Arms & Interventions
aspirin+LMWH group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd
Intervention: Aspirin
aspirin+LMWH group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd
Intervention: Heparin
aspirin+LMWH+immunoglobulin group
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
Intervention: Aspirin
aspirin+LMWH+immunoglobulin group
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
Intervention: Heparin
aspirin+LMWH+immunoglobulin group
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
Intervention: Immunoglobulin
aspirin+LMWH+prednisone group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd
Intervention: Aspirin
aspirin+LMWH+prednisone group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd
Intervention: Heparin
aspirin+LMWH+prednisone group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd
Intervention: Prednisone
aspirin+LMWH+IVIG+prednisone group
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
Intervention: Aspirin
aspirin+LMWH+IVIG+prednisone group
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
Intervention: Heparin
aspirin+LMWH+IVIG+prednisone group
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
Intervention: Prednisone
aspirin+LMWH+IVIG+prednisone group
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
Intervention: Immunoglobulin
dydrogesterone group
dydrogesterone 20-30mg/day, po, tid
Intervention: Dydrogesterone
Outcomes
Primary Outcomes
live birth
Time Frame: through study completion, an average of 3 year
live birth means success pregnancy（more than gestational age of 20 weeks）
Secondary Outcomes
- 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)