A Prospective, Randomized Controlled Study to Evaluate the Effects of Daily Low Dose Aspirin in Pregnant Women With Sickle Cell Disease When Initiated at the First Trimester Versus the Second Trimester of the Gestational Period
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This study is being conducted to evaluate the safety and effect of starting daily use of low dose (100 mg) aspirin in pregnant women with sickle cell disease, who are being followed in two county hospitals in Angola, in the first trimester versus the second trimester of the gestational period.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Healthy Volunteers: f
View:
• 1\. Pregnant women with Sickle Cell Disease 15 years old and older
• 2\. Attending Maternidade Lucrecia Paim, Hospital Materno Infantil Dr. Manuel Pedro Azancot de Menezes, or any health commodities in the neighboring area of the referred hospitals
• 3\. Willing to attend the regular consultations, and consent to take part in the study.
Locations
Other Locations
Angola
Instituto Nacional de Investigação Em Saúde
RECRUITING
Luanda
Contact Information
Primary
TATIANA GOMES, BA/BS/Pre-MD
tatiana.gomes@clincoord.org
+1 213 640 7052
Backup
HELENA TEIXEIRA, PhD
helena.pitangueira@clincoord.org
+55 071 991853687
Time Frame
Start Date: 2024-03-16
Estimated Completion Date: 2026-03-16
Participants
Target number of participants: 450
Treatments
Active_comparator: Aspirin in First trimester
Participants who will start the study medication (Aspirin) during the first trimester
Experimental: Aspirin in Second trimester
Participants who will start the study medication (Aspirin) during the second trimester
Related Therapeutic Areas
Sponsors
Collaborators: FUNDAÇAO CALOUSTE GULBENKIAN, CLINCOORD SERVICES, INC., FUNDACIÓN BANCARIA CAIXA D'ESTALVIS I PENSIONS DE BARCELONA, Escola Superior de Tecnologia da Saúde de Lisboa, ClinCoord Research Center at Luanda Medical Center, CLINCOORD PRESTAÇÃO DE SEVIÇOS, LDA ANGOLA
Leads: Instituto Nacional de Investigacao em Saude, Angola