Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today

NCT06889727 | Completed

• 1 other identifier: GRAV001
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Thalassemia

Outcome Measures

Primary Outcomes (5)

• 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

  15 YEARS

• number of pregnancies spontaneously

  many pregnancies occurred spontaneously

  15 YEARS

• number of pregnancies after hormonal stimulation

  number of pregnancies after hormonal stimulation

  15 YEARS

• likelihood of miscarriage

  To evaluate the likelihood of miscarriage

  15 YEARS

• foetal death

  To evaluate foetal death

  15 YEARS

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: FEMALE
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

FEMALE THALASSEMIE DEPEND TRANSFUSION

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia: lead

Study Sites (1)

UniversityCagliari, OspPed Microcitemico, Cagliari

Cagliari, CAGLIARI, 09123, Italy

Location

MeSH Terms

Conditions

Thalassemia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: August 9, 2023
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)