The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2014
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 7, 2016
CompletedFirst Posted
Study publicly available on registry
December 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2018
CompletedMarch 8, 2017
December 1, 2016
2.7 years
December 7, 2016
March 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
live birth
live birth means success pregnancy（more than gestational age of 20 weeks）
through study completion, an average of 3 year
Secondary Outcomes (3)
D-dimer
through study completion, an average of 3 year
Uterine artery blood flow
through study completion, an average of 3 year
human chorionic gonadotropin
through study completion, an average of 3 year
Study Arms (5)
aspirin+LMWH group
EXPERIMENTALaspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd
aspirin+LMWH+immunoglobulin group
EXPERIMENTALaspirin, 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
aspirin+LMWH+prednisone group
EXPERIMENTALaspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd
aspirin+LMWH+IVIG+prednisone group
EXPERIMENTALaspirin, 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
dydrogesterone group
OTHERdydrogesterone 20-30mg/day, po, tid
Interventions
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- having experienced severe allergies, trauma history and/or operation history within 3 months.
- with a history of mental illness and/or family history of mental illness limb disabled.
- taking medicine within one month.
- suffering major events or having mood swings.
- having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)
- chromosome aberrations in anyone of the couple.
- patients who have drugs contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai first Maternity and Infant health hospital, Tong Ji University
Shanghai, 200051, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 7, 2016
First Posted
December 13, 2016
Study Start
October 1, 2014
Primary Completion
June 10, 2017
Study Completion
December 22, 2018
Last Updated
March 8, 2017
Record last verified: 2016-12