Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
1 other identifier
interventional
600
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2016
Typical duration 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
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 27, 2016
CompletedFirst Posted
Study publicly available on registry
December 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedDecember 9, 2016
November 1, 2016
2.9 years
November 27, 2016
December 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
D-Dimer
through study completion, an average of 3 year
Secondary Outcomes (1)
BMI in kg/m^2
through study completion, an average of 3 year
Study Arms (3)
aspirin group
EXPERIMENTALlow dose aspirin, 75-100mg, bid, after pregnancy
low molecular weight heparin group
EXPERIMENTALlow molecular weight heparin, 4100u, qd, after pregnancy
combination group
EXPERIMENTALlow molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- having experiencedsevere 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
- with a history of recurrent pregnancy loss
- having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine rotine)
- Chromosome aberrations in anyone of the couple.
- patients who have drug 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
November 27, 2016
First Posted
December 8, 2016
Study Start
November 1, 2016
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
December 9, 2016
Record last verified: 2016-11