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| Name | Class |
|---|---|
| FUNDACIÓN BANCARIA CAIXA D'ESTALVIS I PENSIONS DE BARCELONA | UNKNOWN |
| Calouste Gulbenkian Foundation | OTHER |
| CLINCOORD SERVICES, INC. | UNKNOWN |
| CLINCOORD PRESTAÇÃO DE SEVIÇOS, LDA ANGOLA |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin in First trimester | Active Comparator | Participants who will start the study medication (Aspirin) during the first trimester |
|
| Aspirin in Second trimester | Experimental | Participants who will start the study medication (Aspirin) during the second trimester |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 100mg | Drug | Daily use of low dose aspirin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Mortality | Measuring the number of maternal mortalities up to 6 weeks postpartum. | 2 years |
| Life Birth Related Events | The number of preterm births will be measured by the number of deliveries before 37 weeks gestational age. | 2 years |
| Late Abortion Related Events | Measuring the number of unintentional abortions late in the pregnancy | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Morbidity | hypertensive disorders, vaginal bleeding, antepartum hemorrhage, and postpartum hemorrhage, will be aggregated to determine the number of morbidity events related to the mother. | 2 years |
| Fetal Mortality Outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Research Personnel Capacity Building | 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. | 2 years |
| Institutional Collaborations |
Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| JOANA MORAIS, PhD | INSTITUTO NACIONAL DE INVESTIGAÇÃO EM SAÚDE | Principal Investigator |
| TATIANA GOMES, BA/BS/Pre-MD | ClinCoord | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Investigação Em Saúde | Luanda | Luanda Province | 00000 | Angola |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31394941 | 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. | |
| 34389570 | 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. |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D011248 | Pregnancy Complications |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| UNKNOWN |
| Escola Superior de Tecnologia da Saúde de Lisboa | OTHER |
| ClinCoord Research Center at Luanda Medical Center | UNKNOWN |
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fetal loss due to small gestational age, perinatal mortality, spontaneous abortion, and stillbirth, will be aggregated to quantify the number of fetal mortality events.
| 2 years |
| Other Fetal Events | 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. | 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. |
| 2 years |
| 29039130 | 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. |
| 42220645 | Derived | 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. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |