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Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla

NCT ID: NCT02986594

Last Updated: 2016-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-10-31

Brief Summary

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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

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Conditions

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Thrombophilia With Recurrent Pregnancy Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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aspirin group

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

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

low molecular weight heparin group

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

Group Type EXPERIMENTAL

Heparin

Intervention Type DRUG

combination group

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

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Heparin

Intervention Type DRUG

Interventions

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Aspirin

Intervention Type DRUG

Heparin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shihua Bao

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai first Maternity and Infant health hospital, Tong Ji University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Shihua Bao, PhD

Role: primary

Yan Yan, Master

Role: backup

Other Identifiers

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ShanghaiFIMH-0002

Identifier Type: -

Identifier Source: org_study_id