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The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990403
Recruitment Status : Unknown
Verified December 2016 by Shihua Bao, Shanghai First Maternity and Infant Hospital.
Recruitment status was:  Recruiting
First Posted : December 13, 2016
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Shihua Bao, Shanghai First Maternity and Infant Hospital

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.

Condition or disease Intervention/treatment Phase
Recurrent Pregnancy Loss Drug: Aspirin Drug: Heparin Drug: Prednisone Drug: Immunoglobulin Drug: Dydrogesterone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss
Study Start Date : October 2014
Estimated Primary Completion Date : June 10, 2017
Estimated Study Completion Date : December 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: aspirin+LMWH group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection,qd
Drug: Aspirin
Drug: Heparin
Experimental: 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
Drug: Aspirin
Drug: Heparin
Drug: Immunoglobulin
Experimental: 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
Drug: Aspirin
Drug: Heparin
Drug: Prednisone
Experimental: 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
Drug: Aspirin
Drug: Heparin
Drug: Prednisone
Drug: Immunoglobulin
dydrogesterone group
dydrogesterone 20-30mg/day, po, tid
Drug: Dydrogesterone



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. D-dimer [ Time Frame: through study completion, an average of 3 year ]
  2. Uterine artery blood flow [ Time Frame: through study completion, an average of 3 year ]
  3. human chorionic gonadotropin [ Time Frame: through study completion, an average of 3 year ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990403


Locations
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China
Shanghai first Maternity and Infant health hospital, Tong Ji University Recruiting
Shanghai, China, 200051
Contact: Shihua Bao, PhD    86-21-20261430 ext 2012    baoshihua@tongji.edu.cn   
Contact: Yan Yan, Master    86-21-20261430 ext 2012    shtjyanyan@163.com   
Principal Investigator: Shihua Chen, PhD         
Sub-Investigator: Yan Yan, master         
Sponsors and Collaborators
Shanghai First Maternity and Infant Hospital

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Responsible Party: Shihua Bao, Principal Investigator, Shanghai First Maternity and Infant Hospital
ClinicalTrials.gov Identifier: NCT02990403    
Other Study ID Numbers: ShanghaiFMIH-0003
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Abortion, Spontaneous
Fetal Death
Abortion, Habitual
Pregnancy Complications
Death
Pathologic Processes
Aspirin
Prednisone
Heparin
Calcium heparin
Dydrogesterone
Anticoagulants
Immunoglobulins
Antibodies
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action