Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women

October 13, 2016 updated by: Zhongjun Li, Xinqiao Hospital of Chongqing

A Multi-center Prospective Cohort Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women

This clinical study aims to investigate the anti-HPA antibodies caused neonatal alloimmune thrombocytopenia in Chinese pregnant women. The survey and data collect will help form an appropriate clinical screening procedure

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

55497

Contacts and Locations

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

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

Sampling Method

Non-Probability Sample

Study Population

Pregnant Chinese women and their new borns

Description

Inclusion Criteria:

  • 12-28 weeks pregnant Chinese women
  • between Jan 1, 2017 and Dec 31, 2018

Exclusion Criteria:

  • Not willing to participate in this study
  • Plan to terminate pregnancy early

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Pregnant women with anti-HPA antibody negative from the same hospital, the same race, and the same gravidity and parity, who are admitted at the same time.
Procedure: Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion
Observational study.
Experimental Group
pregnant women with anti-HPA antibody positive
Procedure: Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion
Observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The positive rate of anti-HPA antibody
Time Frame: Up to one and a half years after the study completed
Up to one and a half years after the study completed
The morbidity of NAIT
Time Frame: Up to one and a half years after the study completed
Up to one and a half years after the study completed

Secondary Outcome Measures

Outcome Measure
Time Frame
Antigenic specificity of anti-HPA antibodies
Time Frame: Up to one and a half years after the study completed
Up to one and a half years after the study completed
Association of anti-HPA antibody with HLA genotype as assessed by Chi-square test
Time Frame: Up to one and a half years after the study completed
Up to one and a half years after the study completed
The relationship between the titer of anti-HPA antibody and clinical symptom severity in NAIT as assessed by Spearman Correlation assay
Time Frame: Up to one and a half years after the study completed
Up to one and a half years after the study completed

Collaborators and Investigators

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

Sponsor

Xinqiao Hospital of Chongqing

Collaborators

Peking University First Hospital
LanZhou University
RenJi Hospital
Qilu Hospital of Shandong University
Guangzhou First People's Hospital
Shengjing Hospital
Qingdao University
Beijing Chao Yang Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Air Force Military Medical University, China
People's Hospital of Xinjiang Uygur Autonomous Region
The Affiliated Hospital Of Guizhou Medical University
Sir Run Run Shaw Hospital
Second Xiangya Hospital of Central South University
First Affiliated Hospital of Xinjiang Medical University
First Affiliated Hospital Bengbu Medical College
Second Affiliated Hospital of Nanchang University
First Affiliated Hospital of Harbin Medical University
The Affiliated Hospital Of Southwest Medical University
The First Affiliated Hospital of Guangdong Pharmaceutical University
Jilin University
MCH Hospital of Yinchuan City
Henan Province People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (Estimate)

October 17, 2016

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V2.0(20160720)

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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