The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss

NCT ID: NCT02990403

Last Updated: 2017-03-08

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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-12-22

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.

Detailed Description

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Conditions

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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+LMWH group

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

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Heparin

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Heparin

Intervention Type DRUG

Immunoglobulin

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Heparin

Intervention Type DRUG

Prednisone

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Heparin

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Immunoglobulin

Intervention Type DRUG

dydrogesterone group

dydrogesterone 20-30mg/day, po, tid

Group Type OTHER

Dydrogesterone

Intervention Type DRUG

Interventions

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Aspirin

Intervention Type DRUG

Heparin

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Immunoglobulin

Intervention Type DRUG

Dydrogesterone

Intervention Type DRUG

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

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
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

86-21-20261430 ext. 2012

Yan Yan, Master

Role: backup

86-21-20261430 ext. 2012

Other Identifiers

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ShanghaiFMIH-0003

Identifier Type: -

Identifier Source: org_study_id

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