Percorrer por autor "Gomes, Tatiana"
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- Implementation challenges of the learner clinical trial in pregnant women with sickle cell disease in AngolaPublication . Ginete, Catarina; Brito, Miguel; Gomes, Tatiana; Pintangueira, Helena; Mendes, Manuela; Furtado, Ana; Alves, Ligia; Simão, Fernanda; Gonçalves, Mauer; Morais, JoanaSickle Cell Disease (SCD), a severe inherited blood disorder, poses significant risks during pregnancy, particularly in regions like Sub-Saharan Africa, where its prevalence is high. Pregnancy often intensifies the complications associated with SCD, including severe anemia and vaso-occlusive crises, while also elevating the risk of obstetric complications such as pre-eclampsia, eclampsia, intrauterine growth restriction, low birth weight, and maternal or fetal death. These heightened risks underscore the critical importance of close medical surveillance throughout pregnancy. Moreover, there is an urgent need to identify affordable, preventive strategies, especially in low- and middle-income countries where health systems are often overburdened, and resources are limited. Considering these critical needs, clinical research initiatives like the LEARNER clinical study (NCT06417411) are crucial for developing and evaluating interventions that could improve outcomes for pregnant women with SCD in Sub-Saharan Africa. However, conducting such research in countries like Angola is fraught with complex implementation challenges. These include resource limitations in both the research sites and the patient population, and societal norms related to prenatal visits. The use of daily low-dose aspirin is considered safe in pregnant women with SCD and is recommended after 12 weeks of gestational age by the British Society of Hematology for those at severe risk of preeclampsia. The LEARNER Study aims to evaluate the effects of daily low-dose aspirin in SCD pregnancy, comparing its impact on severe outcomes if this prophylactic and affordable medication is started in the first or the second trimester. This study aims to recruit 450 pregnant women with a confirmed SCD diagnosis in multiple maternity and infant hospitals in Luanda, Angola. Consenting patients will be assigned to either the first (weeks 6-13) or second (weeks 14-27) trimester groups, based on their gestational age, as confirmed by ultrasound. Participants will start daily low-dose aspirin and will do regular follow-up appointments till 6 weeks postpartum. Aspirin will be interrupted at week 36, delivery time, or earlier if decided by the clinical team.
- 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 protocolPublication . Brito, Miguel; Ginete, Catarina; Gomes, Tatiana; Pitangueira, Helena; Mendes, Manuela; Furtado, Ana; Alves, Ligia; Simão, Fernanda; Gonçalves, Mauer; Morais, JoanaBackground: Pregnancy in women with Sickle Cell Disease (SCD) is associated with an increased risk of 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: A 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 pregnant women with SCD 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 use 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 child mortality due to SCD and reducing the morbidity in pregnancy and delivery. Trial registration: This study was registered at ClinicalTrials.gov. Trial registration: NCT06417411, on May 16th, 2024.
- Learner-low dose aspirin preterm trial (Angola) – Low dose aspirin in pregnant women with sickle cell disease when started in the first versus second trimester: a clinical control study in AngolaPublication . Brito, Miguel; Ginete, Catarina; Gomes, Tatiana; Pitangueira, Helena; Mendes, Manuela; Furtado, Ana; Alves, Ligia; Simão, Fernanda; Gonçalves, Mauer; Morais, JoanaSickle Cell Disease (SCD) is marked by episodes of acute vaso-occlusive crises, severe anemia, acute chest syndrome, multi-organ damage and stroke, among others. Pregnancy in these patients is associated with an increased risk of adverse outcomes, such as intrauterine growth restriction, perinatal and maternal mortality, low birth weight, eclampsia, pre-eclampsia, and stroke. Therefore, increasing the surveillance during pregnancy and searching prophylactic solutions for early prevention of pregnancy complications in women with SCD in African countries, where the burden of SCD is disproportionally higher, is an urgent need. Aspirin is already widely prescribed for the prevention of cardiovascular complications, and at a low daily dose, is used during pregnancy to prevent preeclampsia, intrauterine growth restriction, and other maternal-and-fetal disorders. In pregnant women with SCD, low dose aspirin is considered safe and is recommended for those who are at severe risk of pre-eclampsia. LEARNER (ClinicalTrials.gov ID, NCT06417411), is a prospective, opened label study to evaluate the effects of daily low dose aspirin in pregnant women with SCD when initiated at the first trimester versus the second trimester of the gestational period (where it is frequently started). We hypothesize that a low dose of aspirin (100 mg/daily) initiated early in pregnancy (weeks 6-13) can be more beneficial, than when it is started in the second trimester (weeks 14-27), reducing the incidence of fetal and maternal complications. This study intends to quantify the reduction in preterm delivery, perinatal death/miscarriage, and the risk of other maternal complications including pre-eclampsia, hypertensive disorders, number of vaso-occlusive crises, need for blood transfusion, urinary tract infections, respiratory tract infections, acute chest syndrome, retained placenta, placental abruption, and vaginal bleeding, when initiating low dose aspirin in the earliest stage of the gestation period. A total of 450 pregnant women, with confirmed diagnosis of SCD, will be enrolled in this study. Enrollment is taking place at maternity and infant hospitals in Luanda, Angola. Patients who consent to participate in the study will be assigned to one of two groups based on their gestational age, confirmed through ultrasound. Participants will then start daily use of 100 mg aspirin; dosing will be suspended at time of delivery, week 36, or earlier, if deemed necessary by the clinical team. Participants will be followed from the consenting visit to 6 weeks post-partum. Recruitment started in April 2024, after regulatory approval (local EC approval nº52/CEMS/2023, and national IRB approval 99/ARMED/MINSA/2024), and to date, 15 participants have been consented and 10 are in the treatment period. The biggest challenge to date is recruiting participants in the first trimester as most pregnant women that visit the hospital, in Angola, are already at the end of the second or in the third trimester. Our strategy to increase the study's visibility and facilitate patient recruitment will be advertisements in social media and patient support groups and to reach out to local health centers around Luanda. Additionally, this study aims to build capacity in Angola for the conduction of future clinical trials, involving local research sites and hospitals, capacitating Angolan institutions and professionals in clinical trial conduction and data capture abilities, promoting national and international collaborations, and creating population awareness for clinical research studies. The study team is comprised of the scientific team, local clinical team, an electronic data capture specialty team, a site management organization (SMO), and a Contract Research Organization (CRO). This is the first of its kind in Angola, which will revolutionize research in the country and help with our understanding of many diseases by diversifying the studied population pool for SCD and all other research that will be conducted in the country following the model established by this study.
- Translating research into practice: implementing the LEARNER SCD pregnancy study in AngolaPublication . Ginete, Catarina; Brito, Miguel; Gomes, Tatiana; Pitangueira, Helena; Mendes, Manuela; Furtado, Ana; Alves, Lígia; Simão, Fernanda; Gonçalves, Mauer; Morais, JoanaIntroduction: Pregnancy in Sickle Cell Disease (SCD), a severe genetic condition highly prevalent in Sub-Saharan Africa, is usually associated with an increase in severe outcomes. Not only do the common symptoms of the disease, such as severe anemia and vaso-occclusive crises, tend to exacerbate, but also the risk of eclampsia, pre-eclampsia, maternal and fetal death, intrauterine growth restrictions, and low birth weight is higher. Medical surveillance during pregnancy is essential, and also, the search for prophylactic and affordable measures is an urgent need, especially in Low- and Middle-income countries with high prevalence of this disease. The use of daily low-dose aspirin is considered safe in pregnant women with SCD and is recommended after 12 weeks of gestational age by the British Society of Haematology for those at severe risk of pre-eclampsia. The LEARNER clinical study (NCT06417411) aims to evaluate the effects of daily low-dose aspirin in SCD pregnancy, comparing its impact on severe outcomes if this prophylactic and affordable medication is started in the first or the second trimester. Methods: This study aims to recruit 450 pregnant women with a confirmed SCD diagnosis in multiple maternity and infant hospitals in Luanda, Angola. Consenting patients will be assigned to the first (weeks 6–13) or second (weeks 14–27) trimester groups according to their gestational age, as confirmed by ultrasound. Participants will start daily low-dose aspirin and will do regular follow-up appointments till 6 weeks postpartum. Aspirin will be interrupted at week 36, delivery time, or earlier if decided by the clinical team. Results: Recruitment started in March 2024, after ethical and regulatory approvals (Parecer no. 52/CEMS/2023, and 99/ARMED/MINSA/2024). In 15 months, 113 women were enrolled in the study, 57 in the first trimester and 56 in the second trimester. To date, 271 severe events, 3 associated with the medication, 9 cases of pre-eclampsia/eclampsia, 36 preterm deliveries, 5 miscarriages, 1 perinatal death, and 4 maternal deaths were registered. Conclusion: The current sample size is too small to draw statistically significant conclusions about the efficacy of starting low-dose daily aspirin earlier in pregnancy. Although the project has been promoted in hospitals and health centers through the media, in newspapers, and on television, to increase the participation in the study, the number of enrolled patients is below the expected, as most pregnant women tend to seek hospital care only during the later stages of pregnancy. It is urgent to invest in health literacy and SCD education in Angola and increase patients' awareness of the need to do prenatal and follow-up consultations during pregnancy for the prevention of pregnancy-associated complications in women with SCD.