Clinical trial NCT06417411: LEARNER- Low dosE AspiRiN prEterm tRial (Angola)
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Sickle Cell Disease
Pregnancy Related
Pregnancy Complications
Pre-Eclampsia
Keywords: LEARNER
ANGOLA
Maternidade Lucrécia Paim
Hospital Materno Infantil Dr Manuel Pedro Azancot de Menezes
Aspirin
Capacity Building
Lead sponsor: Instituto Nacional de Investigacao em Saude, Angola
Sponsor class: OTHER_GOV
Collaborators: name: FUNDACIÓN BANCARIA CAIXA D'ESTALVIS I PENSIONS DE BARCELONA
name: FUNDAÇAO CALOUSTE GULBENKIAN
name: CLINCOORD SERVICES, INC.
name: CLINCOORD PRESTAÇÃO DE SEVIÇOS, LDA ANGOLA
name: Escola Superior de Tecnologia da Saúde de Lisboa
name: ClinCoord Research Center at Luanda Medical Center
First posted: 2024-05-16
Enrollment: 450
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Maternal Mortality
timeFrame: 2 years
measure: Life Birth Related Events
timeFrame: 2 years
measure: Late Abortion Related Events
timeFrame: 2 years
Secondary outcomes:
measure: Maternal Morbidity
timeFrame: 2 years
measure: Fetal Mortality Outcomes
timeFrame: 2 years
measure: Other Fetal Events
timeFrame: 2 years
Other outcomes:
measure: Clinical Research Personnel Capacity Building
timeFrame: 2 years
measure: Institutional Collaborations
timeFrame: 2 years
Locations:
city: Luanda
country: Angola
facility: Instituto Nacional de Investigação Em Saúde
Study officials:
affiliation: INSTITUTO NACIONAL DE INVESTIGAÇÃO EM SAÚDE
name: JOANA MORAIS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ClinCoord
name: TATIANA GOMES, BA/BS/Pre-MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.