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.

BACKGROUND

Pregnancy in women with Sickle Cell Disease (SCD) is associated with an increased risk in severe complications, such as eclampsia, pre-eclampsia, maternal death, intrauterine growth restrictions, perinatal mortality, and low birth weight. Since 50% of these patients are now living to reproductive age, the management of SCD during pregnancy has become pertinent. Searching for prophylactic and affordable measures for early prevention of these complications is urgently needed.

METHODS

Daily low dosage of Aspirin is widely used during pregnancy to prevent pre-eclampsia and other vascular disorders. But the lack of evidence of effectiveness in SCD pregnant women leads to the need to develop clinical trials with this population. In this prospective controlled study, we intend to evaluate the effects of daily low-dose aspirin in pregnant women with SCD, testing the hypothesis that if daily used of low-dose aspirin is initiated early in pregnancy (between 6 and 13 weeks of gestation) versus in the second trimester (between 14 and 27 weeks of gestation), it reduces the incidence of preterm birth mother mortality and miscarriage.

DISCUSSION: The expected impact of the proposed project includes reducing maternal and children mortality due to SCD and reduce the morbidity in pregnancy and delivery.

TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov Trial registration: NCT06417411) in May 16th 2024.