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Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today

Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today: a Multicentre Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06889727
Enrollment
75
Registered
2025-03-21
Start date
2023-08-09
Completion date
2024-05-14
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thalassemia

Brief 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 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.

Interventions

None listed

Sponsors

Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Other types of anemia * Pregnancy not initiated despite assisted fertilization practices * Subjects unwilling to sign informed consent

Design outcomes

Primary

MeasureTime frameDescription
foetal death15 YEARSTo evaluate foetal death
number of pregnancies in women with beta thalassemia followed in Italian centres15 YEARSTo 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 spontaneously15 YEARSmany pregnancies occurred spontaneously
number of pregnancies after hormonal stimulation15 YEARSnumber of pregnancies after hormonal stimulation
likelihood of miscarriage15 YEARSTo evaluate the likelihood of miscarriage

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026