NCT02934906

Brief Summary

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55,497

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

2.9 years

First QC Date

October 11, 2016

Last Update Submit

October 13, 2016

Conditions

Neonatal Alloimmune Thrombocytopenia

Keywords

Neonatal Alloimmune Thrombocytopeniapregnancyhuman platelet allogantigenasianChinese

Outcome Measures

Primary Outcomes (2)

  • The positive rate of anti-HPA antibody

    Up to one and a half years after the study completed

  • The morbidity of NAIT

    Up to one and a half years after the study completed

Secondary Outcomes (3)

  • Antigenic specificity of anti-HPA antibodies

    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

    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

    Up to one and a half years after the study completed

Study Arms (2)

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

Experimental Group

pregnant women with anti-HPA antibody positive

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

Interventions

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

Observational study.

Control GroupExperimental Group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant Chinese women and their new borns

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28859622DERIVED

MeSH Terms

Conditions

Thrombocytopenia, Neonatal Alloimmune

Condition Hierarchy (Ancestors)

ThrombocytopeniaBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Li Chen

CONTACT

0118615178936688chenli200401@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief of Blood Transfusion Department

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 17, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Last Updated

October 17, 2016

Record last verified: 2016-10