The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss

Shanghai First Maternity and Infant Hospital

Status and phase: Unknown; Phase 4

Conditions: Recurrent Pregnancy Loss

Treatments: Drug: Dydrogesterone; Drug: Immunoglobulin; Drug: Aspirin; Drug: Prednisone; Drug: Heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT02990403

ShanghaiFMIH-0003

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

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 limb disabled.
3. taking medicine within one month.
4. suffering major events or having mood swings.
5. having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)
6. chromosome aberrations in anyone of the couple.
7. patients who have drugs contraindications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 5 patient groups

aspirin+LMWH group

Experimental group

Description:

aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd

Treatment:

Drug: Heparin

Drug: Aspirin

aspirin+LMWH+immunoglobulin group

Experimental group

Description:

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

Treatment:

Drug: Heparin

Drug: Immunoglobulin

Drug: Aspirin

aspirin+LMWH+prednisone group

Experimental group

Description:

aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd

Treatment:

Drug: Heparin

Drug: Prednisone

Drug: Aspirin

aspirin+LMWH+IVIG+prednisone group

Experimental group

Description:

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

Treatment:

Drug: Heparin

Drug: Immunoglobulin

Drug: Prednisone

Drug: Aspirin

dydrogesterone group

Other group

Description:

dydrogesterone 20-30mg/day, po, tid

Treatment:

Drug: Dydrogesterone