Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla

Shanghai First Maternity and Infant Hospital

Status and phase: Unknown; Phase 4

Conditions: Thrombophilia With Recurrent Pregnancy Loss

Treatments: Drug: Heparin; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02986594

ShanghaiFIMH-0002

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

aspirin group

Experimental group

Description:

low dose aspirin, 75-100mg, bid, after pregnancy

Treatment:

Drug: Aspirin

low molecular weight heparin group

Experimental group

Description:

low molecular weight heparin, 4100u, qd, after pregnancy

Treatment:

Drug: Heparin

combination group

Experimental group

Description:

low molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy

Treatment:

Drug: Aspirin

Drug: Heparin