Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today

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.

Study Overview

• Status: Completed
• Conditions: Thalassemia

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Italy
  • Cagliari, Italy, 09123
    • UniversityCagliari, OspPed Microcitemico, Cagliari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

FEMALE THALASSEMIE DEPEND TRANSFUSION

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Actual): May 14, 2024
• Study Completion (Actual): May 14, 2024

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Thalassemia
• Other Study ID Numbers: GRAV001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No