Diagnosis and Treatment Strategy of Recurrent Spontaneous... | NCT02986594

Studies
Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla

NCT02986594

Sponsor

Shanghai First Maternity and Infant Hospital

Status

Unknown status

Last Update Posted

Dec 9, 2016Estimated

Enrollment

600Estimated

Phase

Phase 4

Conditions

Thrombophilia With Recurrent Pregnancy Loss

Interventions

Aspirin
Heparin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Oct 2019Estimated

Completion Date

Oct 2019Estimated

First Submitted Date

Nov 27, 2016

First Submission Date that Met QC Criteria

Dec 6, 2016

First Posted Date

Dec 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2016

Last Update Posted Date

Dec 9, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shihua Bao, Principal Investigator, Shanghai First Maternity and Infant HospitalPrincipal Investigator

Lead Sponsor

Shanghai First Maternity and Infant HospitalOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aspirin group	Experimental	low dose aspirin, 75-100mg, bid, after pregnancy	Drug: Aspirin
low molecular weight heparin group	Experimental	low molecular weight heparin, 4100u, qd, after pregnancy	Drug: Heparin
combination group	Experimental	low molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy	Drug: Aspirin Drug: Heparin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aspirin	Drug		aspirin group combination group
Heparin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
D-Dimer		through study completion, an average of 3 year

Secondary Outcomes

Measure	Description	Time Frame
BMI in kg/m^2		through study completion, an average of 3 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai first Maternity and Infant health hospital, Tong Ji University	Recruiting	Shanghai		200051	China

Intervention Browse Module

MeSH Terms

ID	Term
D001241	Aspirin
D006493	Heparin

Ancestor Terms

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided