Sickle Cell Disease, Pregnancy Related, Pregnancy Complications, Pre-Eclampsia
Conditions
Keywords
LEARNER, ANGOLA, Maternidade Lucrécia Paim, Hospital Materno Infantil Dr Manuel Pedro Azancot de Menezes, Aspirin, Capacity Building
Brief 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.
Detailed description
The proposed project is a prospective, randomized controlled study to evaluate the effects of daily low dose aspirin in pregnant women with Sickle Cell Disease at the first trimester versus the second trimester of the gestation period. The study will include 450 female participants of all ages, in multiple maternity hospitals in Luanda, Angola, with an official diagnosis of Sickle Cell Disease and confirmed pregnancy. Patients who consent to take part in the study will be given 100 mg aspirin once daily either at the first trimester (6-13 weeks) or the second trimester (14-27 weeks) of the gestation period. Up to 450 participants will be randomly assigned in a 1:1 ratio to the two study treatment trimester groups (225 starting the low dose of aspirin at the first trimester and 225 starting the low dose of aspirin at the second trimester). In both treatment arms, daily use of low dose aspirin will be prescribed/administered until week 36 or time of delivery, whichever comes earlier. Study Duration: Each participant will be enrolled in the study for the duration of the pregnancy as follow: Screening Visit Randomized Treatment Period Follow Up Period (6 weeks postpartum)
Interventions
DRUGAspirin 100mg
Daily use of low dose aspirin.
Sponsors
FUNDACIÓN BANCARIA CAIXA D'ESTALVIS I PENSIONS DE BARCELONA
FUNDAÇAO CALOUSTE GULBENKIAN
CLINCOORD SERVICES, INC.
CLINCOORD PRESTAÇÃO DE SEVIÇOS, LDA ANGOLA
Escola Superior de Tecnologia da Saúde de Lisboa
ClinCoord Research Center at Luanda Medical Center
Instituto Nacional de Investigacao em Saude, Angola
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 1\. Pregnant women with Sickle Cell Disease in the third trimester (after week 27) * 2\. HIV infection * 3\. Diabetes mellitus * 4\. Chronic hypertension * 5\. Liver disease measured by laboratory indication being 3 times above the upper limit of normal * 6\. Sickle nephropathy * 7\. Multiple pregnancies * 8\. Hypersensitivity to aspirin * 9\. History of blood transfusion in the last 3 months * 10.Those who did not consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late Abortion Related Events | 2 years | Measuring the number of unintentional abortions late in the pregnancy |
| Life Birth Related Events | 2 years | The number of preterm births will be measured by the number of deliveries before 37 weeks gestational age. |
| Maternal Mortality | 2 years | Measuring the number of maternal mortalities up to 6 weeks postpartum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other Fetal Events | 2 years | Early preterm delivery (less than 34 weeks of gestation), extreme preterm delivery (less than 28 weeks of gestation), actual birth weight (measured in grams), post-term delivery (more than 42 weeks of gestation) will be combined to report the number of other fetal related events. |
| Maternal Morbidity | 2 years | hypertensive disorders, vaginal bleeding, antepartum hemorrhage, and postpartum hemorrhage, will be aggregated to determine the number of morbidity events related to the mother. |
| Fetal Mortality Outcomes | 2 years | fetal loss due to small gestational age, perinatal mortality, spontaneous abortion, and stillbirth, will be aggregated to quantify the number of fetal mortality events. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical Research Personnel Capacity Building | 2 years | The number of investigators and research staff successfully trained will be combined to measure the ability of conducting clinical research and data capture by otherwise research naive personnel. |
| Institutional Collaborations | 2 years | The number of institutions involved in the conduction of the LEARNER project will be reported to measure collaboration between Angolan scientific/medical institutions and other international research entities. |
Countries
Angola
Contacts
Primary ContactTATIANA GOMES, BA/BS/Pre-MD
Backup ContactHELENA TEIXEIRA, PhD
Outcome results
None listed