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Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla

Primary Purpose

Thrombophilia With Recurrent Pregnancy Loss

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Aspirin
Heparin
Sponsored by
Shanghai First Maternity and Infant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombophilia With Recurrent Pregnancy Loss

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai first Maternity and Infant health hospital, Tong Ji UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

aspirin group

low molecular weight heparin group

combination group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

D-Dimer

Secondary Outcome Measures

BMI in kg/m^2

Full Information

First Posted
November 27, 2016
Last Updated
December 8, 2016
Sponsor
Shanghai First Maternity and Infant Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02986594
Brief Title
Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla
Official Title
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai First Maternity and Infant Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombophilia With Recurrent Pregnancy Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aspirin group
Arm Type
Experimental
Arm Description
low dose aspirin, 75-100mg, bid, after pregnancy
Arm Title
low molecular weight heparin group
Arm Type
Experimental
Arm Description
low molecular weight heparin, 4100u, qd, after pregnancy
Arm Title
combination group
Arm Type
Experimental
Arm Description
low molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Type
Drug
Intervention Name(s)
Heparin
Primary Outcome Measure Information:
Title
D-Dimer
Time Frame
through study completion, an average of 3 year
Secondary Outcome Measure Information:
Title
BMI in kg/m^2
Time Frame
through study completion, an average of 3 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Facility Information:
Facility Name
Shanghai first Maternity and Infant health hospital, Tong Ji University
City
Shanghai
ZIP/Postal Code
200051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shihua Bao, PhD
Phone
86-21-20261430
Ext
2012
Email
baoshihua@tongji.edu.cn
First Name & Middle Initial & Last Name & Degree
Yan Yan, Master
Phone
86-21-20261430
Ext
2012
Email
shtjyanyan@163.com
First Name & Middle Initial & Last Name & Degree
Shihua Chen, PhD
First Name & Middle Initial & Last Name & Degree
Yan Yan, master

12. IPD Sharing Statement

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Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla

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