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The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss

Primary Purpose

Recurrent Pregnancy Loss

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Aspirin
Heparin
Prednisone
Immunoglobulin
Dydrogesterone
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 Recurrent Pregnancy Loss

Eligibility Criteria

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

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

aspirin+LMWH group

aspirin+LMWH+immunoglobulin group

aspirin+LMWH+prednisone group

aspirin+LMWH+IVIG+prednisone group

dydrogesterone group

Arm Description

aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd

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

aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd

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

dydrogesterone 20-30mg/day, po, tid

Outcomes

Primary Outcome Measures

live birth
live birth means success pregnancy（more than gestational age of 20 weeks）

Secondary Outcome Measures

D-dimer
Uterine artery blood flow
human chorionic gonadotropin

Full Information

First Posted
December 7, 2016
Last Updated
March 6, 2017
Sponsor
Shanghai First Maternity and Infant Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02990403
Brief Title
The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss
Official Title
The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 10, 2017 (Anticipated)
Study Completion Date
December 22, 2018 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aspirin+LMWH group
Arm Type
Experimental
Arm Description
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd
Arm Title
aspirin+LMWH+immunoglobulin group
Arm Type
Experimental
Arm Description
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
Arm Title
aspirin+LMWH+prednisone group
Arm Type
Experimental
Arm Description
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd
Arm Title
aspirin+LMWH+IVIG+prednisone group
Arm Type
Experimental
Arm Description
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
Arm Title
dydrogesterone group
Arm Type
Other
Arm Description
dydrogesterone 20-30mg/day, po, tid
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Type
Drug
Intervention Name(s)
Immunoglobulin
Intervention Type
Drug
Intervention Name(s)
Dydrogesterone
Primary Outcome Measure Information:
Title
live birth
Description
live birth means success pregnancy（more than gestational age of 20 weeks）
Time Frame
through study completion, an average of 3 year
Secondary Outcome Measure Information:
Title
D-dimer
Time Frame
through study completion, an average of 3 year
Title
Uterine artery blood flow
Time Frame
through study completion, an average of 3 year
Title
human chorionic gonadotropin
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 2 miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form. Exclusion Criteria: 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
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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The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss

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