The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss

March 6, 2017 updated by: Shihua Bao, Shanghai First Maternity and Infant Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200051
        • Recruiting
        • Shanghai first Maternity and Infant health hospital, Tong Ji University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aspirin+LMWH group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd
Drug: Aspirin
Drug: Heparin
Experimental: aspirin+LMWH+immunoglobulin group
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
Drug: Aspirin
Drug: Immunoglobulin
Drug: Heparin
Experimental: aspirin+LMWH+prednisone group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd
Drug: Prednisone
Drug: Aspirin
Drug: Heparin
Experimental: aspirin+LMWH+IVIG+prednisone group
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
Drug: Prednisone
Drug: Aspirin
Drug: Immunoglobulin
Drug: Heparin
Other: dydrogesterone group
dydrogesterone 20-30mg/day, po, tid
Drug: Dydrogesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth
Time Frame: through study completion, an average of 3 year
live birth means success pregnancy（more than gestational age of 20 weeks）
through study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
D-dimer
Time Frame: through study completion, an average of 3 year
through study completion, an average of 3 year
Uterine artery blood flow
Time Frame: through study completion, an average of 3 year
through study completion, an average of 3 year
human chorionic gonadotropin
Time Frame: through study completion, an average of 3 year
through study completion, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai First Maternity and Infant Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

June 10, 2017

Study Completion (Anticipated)

December 22, 2018

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (Estimate)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiFMIH-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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