Neonatal Alloimmune ThrombocytopeniaNCT02934906
Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women
An observational study of Neonatal Alloimmune Thrombocytopenia, run by Xinqiao Hospital of Chongqing.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Alloimmune Thrombocytopenia
- What is being tested?
- Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 55,497 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant Chinese women and their new borns
Who may be able to join
- 12-28 weeks pregnant Chinese women
- between Jan 1, 2017 and Dec 31, 2018
Who cannot join
- Not willing to participate in this study
- Plan to terminate pregnancy early
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
- Conditions
- Neonatal Alloimmune Thrombocytopenia
- Being tested
- Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion
- Keywords
- Neonatal Alloimmune Thrombocytopenia, pregnancy, human platelet allogantigen, asian, Chinese
- Medical subject headings
- Thrombocytopenia, Neonatal Alloimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusionProcedure or surgery
Observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion | |
| Experimental Group | pregnant women with anti-HPA antibody positive Receives: Procedure: Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The positive rate of anti-HPA antibody
Measured: Up to one and a half years after the study completed
The morbidity of NAIT
Measured: Up to one and a half years after the study completed
Secondary outcomes (3)
Antigenic specificity of anti-HPA antibodies
Measured: 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
Measured: 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
Measured: Up to one and a half years after the study completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Alloimmune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55,497 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China, Shengjing Hospital, Qilu Hospital of Shandong University, Second Xiangya Hospital of Central South University, LanZhou University, The First Affiliated Hospital of Bengbu Medical University, The Affiliated Hospital Of Guizhou Medical University, Sir Run Run Shaw Hospital, Jilin University, First Affiliated Hospital of Xinjiang Medical University, People's Hospital of Xinjiang Uygur Autonomous Region, Second Affiliated Hospital of Nanchang University, Guangzhou First People's Hospital, The Affiliated Hospital Of Southwest Medical University, Beijing Chao Yang Hospital, Qingdao University, Peking University First Hospital, RenJi Hospital, First Affiliated Hospital of Harbin Medical University, MCH Hospital of Yinchuan City, Henan Provincial People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Guangdong Pharmaceutical University
- Responsible party
- Principal investigator, Zhongjun Li, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934906
- Sponsor's protocol ID
- V2.0(20160720)
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2016
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28859622
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Cohort Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women
- ClinicalTrials.gov ID
- NCT02934906
- Acronym / sponsor ID
- V2.0(20160720)
- Conditions
- Neonatal Alloimmune Thrombocytopenia
- Keywords
- Neonatal Alloimmune Thrombocytopenia, pregnancy, human platelet allogantigen, asian, Chinese
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55,497 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China, Shengjing Hospital, Qilu Hospital of Shandong University, Second Xiangya Hospital of Central South University, LanZhou University, The First Affiliated Hospital of Bengbu Medical University, The Affiliated Hospital Of Guizhou Medical University, Sir Run Run Shaw Hospital, Jilin University, First Affiliated Hospital of Xinjiang Medical University, People's Hospital of Xinjiang Uygur Autonomous Region, Second Affiliated Hospital of Nanchang University, Guangzhou First People's Hospital, The Affiliated Hospital Of Southwest Medical University, Beijing Chao Yang Hospital, Qingdao University, Peking University First Hospital, RenJi Hospital, First Affiliated Hospital of Harbin Medical University, MCH Hospital of Yinchuan City, Henan Provincial People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Guangdong Pharmaceutical University
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Procedure: Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusionPregnant 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. |
| Experimental Group | – | Procedure: Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusionpregnant women with anti-HPA antibody positive |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant Chinese women and their new borns
Key inclusion criteria (2 listed)
- 12-28 weeks pregnant Chinese women
- between Jan 1, 2017 and Dec 31, 2018
Key exclusion criteria (2 listed)
- Not willing to participate in this study
- Plan to terminate pregnancy early
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusionObservational study. | Procedure or surgery | Control Group, Experimental Group |
Primary outcome
The positive rate of anti-HPA antibody
Time frame: 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
3 secondary outcomes
Antigenic specificity of anti-HPA antibodies
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Derived from this study: PubMed 28859622Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Alloimmune Thrombocytopenia, run by Xinqiao Hospital of Chongqing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Chen (0118615178936688, chenli200401@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The positive rate of anti-HPA antibody (time frame: Up to one and a half years after the study completed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02934906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.