drugset / Trial / NCT06417411
LEARNER- Low dosE AspiRiN prEterm tRial (Angola)
Phase 1/2
Active not recruiting
450 enrolled
Instituto Nacional de Investigacao em Saude, Angola
CLINCOORD PRESTAÇÃO DE SEVIÇOS, LDA ANGOLA · collabCLINCOORD SERVICES, INC. · collabCalouste Gulbenkian Foundation · collabClinCoord Research Center at Luanda Medical Center · collabEscola Superior de Tecnologia da Saúde de Lisboa · collabFUNDACIÓN BANCARIA CAIXA D'ESTALVIS I PENSIONS DE BARCELONA · collab
Non-randomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2024-03-16
- Primary completion
- 2026-03-30
- Completion
- 2026-10-16
Publications
- Background Borges E, Tchonhi C, Couto CSB, Gomes V, Amorim A, Prata MJ, Brito M. Unusual beta-Globin Haplotype Distribution in Newborns from Bengo, Angola. Hemoglobin. 2019 May;43(3):149-154. doi: 10.1080/03630269.2019.1647230. Epub 2019 Aug 8.
- Background Afolabi BB, Babah OA, Adeyemo TA, Odukoya OO, Ezeaka CV, Nwaiwu O, Oshodi YA, Ogunnaike BA. Low-dose aspirin for preventing intrauterine growth restriction and pre-eclampsia in sickle cell pregnancy (PIPSICKLE): a randomised controlled trial (study protocol). BMJ Open. 2021 Aug 13;11(8):e047949. doi: 10.1136/bmjopen-2020-047949.
- Background Atallah A, Lecarpentier E, Goffinet F, Doret-Dion M, Gaucherand P, Tsatsaris V. Aspirin for Prevention of Preeclampsia. Drugs. 2017 Nov;77(17):1819-1831. doi: 10.1007/s40265-017-0823-0.
- Brito M, Ginete C, Gomes T, Pitangueira H, Mendes M, Furtado A, Alves L, Simao F, Goncalves M, Morais J. LEARNER - 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 - study protocol. Contemp Clin Trials Commun. 2026 May 18;51:101649. doi: 10.1016/j.conctc.2026.101649. eCollection 2026 Jun.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 100 mg | — |