Pregnant WomenNCT06001905
Research on the Construction of Cord Blood Storage Decision Aid Network Platform Based on "Internet +"
An observational study of Pregnant Women, run by Qianfoshan Hospital at 1 site in China.
Trial summary
Cord blood, as an important alternative source of hematopoietic stem cells, can be used to reconstruct bone marrow hematopoietic and immune function, and is an effective means to treat children with blood diseases. 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
- Pregnant Women
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2022to 10 Jul 2024
- 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: Only pregnant women have the right to decide whether to store umbilical cord blood. Therefore, pregnant women who have been registered in our hospital were selected in this study. The first test should be performed after 12 weeks of gestation, so pregnant women over 12 weeks of gestation should be selected.
Who may be able to join
- Age > 18 years old;
- Pregnant women whose gestational age ≥12 weeks and registered in our hospital;
- With a certain level of education, can complete the questionnaire independently;
- Informed consent to participate in the study
Who cannot join
- There are patients with mental illness;
- Participated in other clinical studies in the past three months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongguo
Jinan, 250014
change li master, lichange, 1716387014@qq.com
About this study
Cord blood, as an important alternative source of hematopoietic stem cells, can be used to reconstruct bone marrow hematopoietic and immune function, and is an effective means to treat children with blood diseases. However, at present, the collection rate of cord blood is not high in our country, only the mother have the right to decide whether or not. At the same time, domestic studies on cord blood collection are still very limited, for the lack of effective programs and policies, which can not provide help to improve the collection level of cord blood. Therefore, in order to improve the rate of umbilical cord blood collection, it is particularly necessary to build tools to help pregnant women decide whether to retain cord blood. This topic will investigate and analyze the cognition and retention intention of pregnant women for umbilical cord blood collection. At the same time, the related process of pregnant women for umbilical cord blood retention will be deeply explored. Based on the results of quantitative and qualitative investigation, Internet technology will be used to build a network platform for pregnant women for umbilical cord blood storage decision AIDS, and the effectiveness of this tool will be evaluated. To provide theoretical basis for clinical medical workers and umbilical cord blood bank staff to establish the decision plan of cord blood storage.
- Conditions
- Pregnant Women
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct the network platform of cord blood storage decision aid tool
Construct the network platform of cord blood storage decision aid tool based on "Internet +" and apply it to clinical practice to provide support and help for pregnant women in cord blood storage decision, avoid decision regret, and improve pregnant women's willingness and satisfaction in cord blood storage.
Measured: 2024.07.10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start10 Jul 2022
- Primary completion10 Jul 2024 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Nursing Association
- Responsible party
- Principal investigator, Hong Ji, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001905
- Sponsor's protocol ID
- YXLL-KY-2023(059)
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Construction of Cord Blood Storage Decision Aid Network Platform Based on "Internet +"
- ClinicalTrials.gov ID
- NCT06001905
- Acronym / sponsor ID
- YXLL-KY-2023(059)
- Conditions
- Pregnant Women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Collaborators
- Shandong Nursing Association
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 21 Aug 2023 (actual)
- 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.
Cord blood, as an important alternative source of hematopoietic stem cells, can be used to reconstruct bone marrow hematopoietic and immune function, and is an effective means to treat children with blood diseases. However, at present, the collection rate of cord blood is not high in our country, only the mother have the right to decide whether or not. At the same time, domestic studies on cord blood collection are still very limited, for the lack of effective programs and policies, which can not provide help to improve the collection level of cord blood. Therefore, in order to improve the rate of umbilical cord blood collection, it is particularly necessary to build tools to help pregnant women decide whether to retain cord blood. This topic will investigate and analyze the cognition and retention intention of pregnant women for umbilical cord blood collection. At the same time, the related process of pregnant women for umbilical cord blood retention will be deeply explored. Based on the results of quantitative and qualitative investigation, Internet technology will be used to build a network platform for pregnant women for umbilical cord blood storage decision AIDS, and the effectiveness of this tool will be evaluated. To provide theoretical basis for clinical medical workers and umbilical cord blood bank staff to establish the decision plan of cord blood storage.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Only pregnant women have the right to decide whether to store umbilical cord blood. Therefore, pregnant women who have been registered in our hospital were selected in this study. The first test should be performed after 12 weeks of gestation, so pregnant women over 12 weeks of gestation should be selected.
Key inclusion criteria (4 listed)
- Age > 18 years old;
Key exclusion criteria (2 listed)
- There are patients with mental illness;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Construct the network platform of cord blood storage decision aid tool
Time frame: 2024.07.10
Construct the network platform of cord blood storage decision aid tool based on "Internet +" and apply it to clinical practice to provide support and help for pregnant women in cord blood storage decision, avoid decision regret, and improve pregnant women's willingness and satisfaction in cord blood storage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women, run by Qianfoshan Hospital at 1 site in China.
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 4 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ji Hong, master (13791120369, honghongji-2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construct the network platform of cord blood storage decision aid tool (time frame: 2024.07.10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2023.