HemoglobinopathiesNCT04029142
Screening for Hemoglobinopathies in Pregnant Women
An observational study of Hemoglobinopathies, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This prospective monocentric study project is to identify hemoglobinopathies in pregnant women in order to optimize antenatal care and to investigate the prevalence of hemoglobinopathies in pregnant women in Switzerland. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemoglobinopathies
- What is being tested?
- Review of routine lab data
- How many people
- 1,785 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Jul 2019to 30 Sep 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: pregnant women seen at the Frauenklinik at University Hospital Basel
Who may be able to join
- pregnant women seen at the Frauenklinik at University Hospital Basel
Who cannot join
- pregnant women with already known hemoglobinopathy
- refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
This prospective monocentric study project is to identify hemoglobinopathies in pregnant women in order to optimize antenatal care and to investigate the prevalence of hemoglobinopathies in pregnant women in Switzerland.
- Conditions
- Hemoglobinopathies
- Being tested
- Review of routine lab data
- Keywords
- thalassemia, sickle cell anaemia, molecular genetic analysis
- Medical subject headings
- Hemoglobinopathies, Thalassemia, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Review of routine lab dataDiagnostic test
Review of routine lab data from pregnant women (first trimester)
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of hemoglobinopathies
identification of hemoglobinopathies by investigating routine lab samples
Measured: single time point assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start3 Jul 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
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 HemoglobinopathiesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,785 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Hoesli, Prof. Dr., Principal investigator, Frauenklinik Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029142
- Sponsor's protocol ID
- 2019-01065; sp19Amstad
- Other IDs
- 2019
- Status last verified
- Feb 2024
- First submitted
- 17 Jul 2019
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amstad Bencaiova G, Geissler F, Hoesli I. Cohort profile: targeted antenatal screening for haemoglobinopathies in Basel. BMJ Open. 2020 Jul 22;10(7):e035735. doi: 10.1136/bmjopen-2019-035735.
PubMed 32699163
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Hemoglobinopathies in Pregnant Women
- ClinicalTrials.gov ID
- NCT04029142
- Acronym / sponsor ID
- 2019-01065; sp19Amstad
- Conditions
- Hemoglobinopathies
- Keywords
- thalassemia, sickle cell anaemia, molecular genetic analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,785 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 23 Jul 2019 (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.
This prospective monocentric study project is to identify hemoglobinopathies in pregnant women in order to optimize antenatal care and to investigate the prevalence of hemoglobinopathies in pregnant women in Switzerland.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women seen at the Frauenklinik at University Hospital Basel
Key inclusion criteria (1 listed)
- pregnant women seen at the Frauenklinik at University Hospital Basel
Key exclusion criteria (2 listed)
- pregnant women with already known hemoglobinopathy
- refusal of participation
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 |
|---|---|---|
| Review of routine lab dataReview of routine lab data from pregnant women (first trimester) | Diagnostic test | – |
Primary outcome
identification of hemoglobinopathies
Time frame: single time point assessment at baseline
identification of hemoglobinopathies by investigating routine lab samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Results publication: PubMed 32699163Amstad Bencaiova G, Geissler F, Hoesli I. Cohort profile: targeted antenatal screening for haemoglobinopathies in Basel. BMJ Open. 2020 Jul 22;10(7):e035735. doi: 10.1136/bmjopen-2019-035735.
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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.
Irene Hoesli, Prof. Dr. principal investigator
Frauenklinik Universitätsspital Basel
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 Hemoglobinopathies, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 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: finished, as of the sponsor's last update on 4 Mar 2024. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identification of hemoglobinopathies (time frame: single time point assessment at baseline). 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 NCT04029142, 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 4 Mar 2024.