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

NCT ID: NCT02934906

Last Updated: 2016-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

55497 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Neonatal Alloimmune Thrombocytopenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion

Intervention Type PROCEDURE

Observational study.

Experimental Group

pregnant women with anti-HPA antibody positive

Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion

Intervention Type PROCEDURE

Observational study.

Interventions

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Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion

Observational study.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Bengbu Medical University

OTHER

Sponsor Role collaborator

The Affiliated Hospital Of Guizhou Medical University

OTHER

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

Jilin University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

Guangzhou First People's Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital Of Southwest Medical University

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Qingdao University

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

MCH Hospital of Yinchuan City

UNKNOWN

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangdong Pharmaceutical University

OTHER

Sponsor Role collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role lead

Responsible Party

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Zhongjun Li

Professor, Chief of Blood Transfusion Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Li Chen

Role: CONTACT

0118615178936688

References

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Chen L, Liu Z, Liu T, Ma X, Rao M, Wang Y, Sun B, Yin W, Zhang J, Yan B, Li X, Wang Q, Zhang L, Wen J, Liu F, Wang P, Wei Y, Huang Y, Wu J, Guo Y, Kang Y, Song X, Liu X, Zhang G, Xie T, Chen Y, Zeng X, Li Z. Neonatal alloimmune thrombocytopenia caused by anti-HPA antibodies in pregnant Chinese women: a study protocol for a multicentre, prospective cohort trial. BMC Pregnancy Childbirth. 2017 Aug 31;17(1):281. doi: 10.1186/s12884-017-1453-y.

Reference Type DERIVED
PMID: 28859622 (View on PubMed)

Other Identifiers

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V2.0(20160720)

Identifier Type: -

Identifier Source: org_study_id

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