ThalassemiaNCT06889727
Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today
An observational study of Thalassemia, run by Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia at 1 site in Italy.
Trial summary
Recent advances in the management of thalassemia have significantly improved life expectancy and quality of life of patients with this hemoglobinopathy, with a consequent increase in their reproductive potential and desire to have children.Since an initial report of a successful pregnancy in a woman with thalassemia… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Thalassemia
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 9 Aug 2023to 14 May 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: FEMALE THALASSEMIE DEPEND TRANSFUSION
Who may be able to join
- Transfusion dependent and nontransfusion- dependent thalassemia
- Pregnancy ended with the birth of a live or dead foetus
- Pregnancy ended in miscarriage or voluntary abortion
- Pregnancy in progress
Who cannot join
- Other types of anemia
- Pregnancy not initiated despite assisted fertilization practices
- Subjects unwilling to sign informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
UniversityCagliari, OspPed Microcitemico, Cagliari
Cagliari, CAGLIARI, 09123
About this study
Official title: Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today: a Multicentre Observational Study
Recent advances in the management of thalassemia have significantly improved life expectancy and quality of life of patients with this hemoglobinopathy, with a consequent increase in their reproductive potential and desire to have children.Since an initial report of a successful pregnancy in a woman with thalassemia major by Walker in 1969, hundreds of pregnancies have been reported so far, highlighting that women carefully managed in the preconception phase usually carry out a successful gestation and labor, both in case of spontaneous conception and assisted reproductive techniques.
- Conditions
- Thalassemia
- Medical subject headings
- Thalassemia
What is being measured
The primary outcome is the main question the study is designed to answer.
number of pregnancies in women with beta thalassemia followed in Italian centres
To evaluate the number of pregnancies in women with beta thalassemia followed in Italian centres and how the increase in the average age of the thalassemia population impact on the number of new pregnancies over time
Measured: 15 YEARS
number of pregnancies spontaneously
many pregnancies occurred spontaneously
Measured: 15 YEARS
number of pregnancies after hormonal stimulation
number of pregnancies after hormonal stimulation
Measured: 15 YEARS
likelihood of miscarriage
To evaluate the likelihood of miscarriage
Measured: 15 YEARS
foetal death
To evaluate foetal death
Measured: 15 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start9 Aug 2023
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies 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
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889727
- Sponsor's protocol ID
- GRAV001
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- 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 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today: a Multicentre Observational Study
- ClinicalTrials.gov ID
- NCT06889727
- Acronym / sponsor ID
- GRAV001
- Conditions
- Thalassemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in ItaliaUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 21 Mar 2025 (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.
Recent advances in the management of thalassemia have significantly improved life expectancy and quality of life of patients with this hemoglobinopathy, with a consequent increase in their reproductive potential and desire to have children.Since an initial report of a successful pregnancy in a woman with thalassemia major by Walker in 1969, hundreds of pregnancies have been reported so far, highlighting that women carefully managed in the preconception phase usually carry out a successful gestation and labor, both in case of spontaneous conception and assisted reproductive techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- FEMALE THALASSEMIE DEPEND TRANSFUSION
Key inclusion criteria (4 listed)
- Transfusion dependent and nontransfusion- dependent thalassemia
- Pregnancy ended with the birth of a live or dead foetus
- Pregnancy ended in miscarriage or voluntary abortion
- Pregnancy in progress
Key exclusion criteria (3 listed)
- Other types of anemia
- Pregnancy not initiated despite assisted fertilization practices
- Subjects unwilling to sign informed consent
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
number of pregnancies in women with beta thalassemia followed in Italian centres
Time frame: 15 YEARS
To evaluate the number of pregnancies in women with beta thalassemia followed in Italian centres and how the increase in the average age of the thalassemia population impact on the number of new pregnancies over time
number of pregnancies spontaneously
Time frame: 15 YEARS
many pregnancies occurred spontaneously
number of pregnancies after hormonal stimulation
Time frame: 15 YEARS
number of pregnancies after hormonal stimulation
likelihood of miscarriage
Time frame: 15 YEARS
To evaluate the likelihood of miscarriage
foetal death
Time frame: 15 YEARS
To evaluate foetal death
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 21 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Thalassemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingObservational study
Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
Not yet recruiting
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
Transfusion-dependent Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thalassemia, run by Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia at 1 site in Italy.
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 3 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 21 Mar 2025. 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 Italy. 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?
number of pregnancies in women with beta thalassemia followed in Italian centres (time frame: 15 YEARS). The study lists 5 primary outcomes in all. 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 Mar 2025.