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Completed

NCT Number: NCT06889727

Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today

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.

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Key information

Conditions

Thalassemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

UniversityCagliari, OspPed Microcitemico, Cagliari

Cagliari, CAGLIARI, 09123, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. number of pregnancies spontaneously

    Time frame: 15 YEARS

    many pregnancies occurred spontaneously

  3. number of pregnancies after hormonal stimulation

    Time frame: 15 YEARS

    number of pregnancies after hormonal stimulation

  4. likelihood of miscarriage

    Time frame: 15 YEARS

    To evaluate the likelihood of miscarriage

  5. foetal death

    Time frame: 15 YEARS

    To evaluate foetal death

Sponsors and collaborators

Lead sponsor

Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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