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- Capacity building in obstetric and abdominal ultrasound for sickle cell disease pregnancies in Angola: a pre- and post-training evaluationPublication . Ribeiro, Ricardo Teresa; Hcini, Najeh; Vasconcelos, Jocelyne; Alves, Ligia; Mendes, Manuela; Gomes, Tatiana M.; Brito, Miguel; Pomar, LéoObjectives: Sickle cell disease (SCD) increases risks in pregnancy, affecting both maternal and fetal outcomes. Ultrasound (US) is essential for monitoring these high-risk pregnancies. However, in countries like Angola, where SCD affects nearly 3% of pregnancies, access to skilled professionals is limited. This study evaluated the impact of an intensive US training program in Luanda, focusing on obstetric and abdominal US for SCD pregnancies. Methods: A prospective pre-post intervention study was conducted with 24 healthcare professionals working in 2 maternity units. Participants completed a survey to assess confidence in performing US procedures before and after a 1-week intensive training program. The training consisted of didactic lectures, supervised hands-on practice with real patients, and case discussions. Statistical analysis included distribution analysis and frequency, Mann-Whitney U tests, and effect sizes. Results: Pre-training, participants demonstrated limited experience with both abdominal and obstetric US in SCD pregnancies. Post-training, improvements were observed in assessments of abdominal organs and obstetric evaluations, with significance in Doppler assessments. Conclusion: The program effectively improved US proficiency and confidence in assessing SCD pregnancies. Incorporating continuous mentorship and locally adapted protocols could sustain these gains, with potential long-term benefits in maternal and fetal outcomes. Future initiatives should incorporate digital mentorship and refresher training.
- 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.
- Sickle cell disease: can genetic variability influence pregnancy outcomes?Publication . Ginete, Catarina; Cruz, Carolina; Delgadinho, Mariana; Mendes, Manuela; Simão, Fernanda; Alves, Ligia; Vasconcelos, Jocelyne; Borralho, Paula; Brito, MiguelPregnancy in Sickle Cell Disease (SCD), a severe hereditary genetic condition, highly prevalent in Sub-Saharan African countries, is associated with increased risk of complications and severe outcomes in pregnancy, like intrauterine growth restriction, low birth weight, premature birth, miscarriage, stillbirth, pre-eclampsia, and maternal mortality. Several factors have been identified as associated with the heterogeneity of SCD phenotypes, namely the hemoglobin subunit beta (HBB) haplotype and −3.7 kb α-thalassemia deletion. Objective: This study aimed to identify pregnancy complications and severe outcomes, and their association with genetic variability in women with SCD. Methods: In a cohort of 162 pregnant women followed at Maternidade Lucrécia Paim, Luanda, Angola, we collected clinical, hematological, biochemical, and genetic data (Sickle Cell Disease genotype, HBB haplotype, and −3.7 kb α-thalassemia). Findings: The Central African Republic (CAR) haplotype was the most prevalent, being 87% of women homozygous. For the −3.7 kb α-gene deletion, 11.7% of women were homozygous, and 36.4% were heterozygous. In this cohort, CAR/CAR women had over 9 times higher odds of having a premature birth, and homozygous women for the −3.7 kb α-thalassemia had over four times higher odds of having a livebirth than the other genotypes. Over 50% of babies were born with low birth weight, and 52,7% were considered premature. Severe maternal complications were registered in 68% of current pregnancies. Conclusion: These findings highlight the high burden of adverse outcomes in SCD pregnancy and the need for individualized and closer healthcare, especially in low and middle-income countries.