LEARNER- Low dosE AspiRiN prEterm tRial (Angola)

Sickle Cell Disease Clinical Trial

— LEARNER  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417411
• Other study ID #: LEARNER
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 16, 2024
• Est. completion date: March 16, 2026

Study information

• Verified date: May 2024
• Source: Instituto Nacional de Investigacao em Saude, Angola
• Contact: TATIANA GOMES, BA/BS/Pre-MD
• Phone: +1 213 640 7052
• Email: tatiana.gomes[@]clincoord.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: March 16, 2026
• Est. primary completion date: March 16, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Eclampsia
• Pre-Eclampsia
• Pregnancy Complications
• Pregnancy Related
• Sickle Cell Disease

Intervention

Drug:
• Aspirin 100mg
Daily use of low dose aspirin.

Locations

Country	Name	City	State
Angola	Instituto Nacional de Investigação Em Saúde	Luanda

Sponsors (7)

Lead Sponsor	Collaborator
Instituto Nacional de Investigacao em Saude, Angola	CLINCOORD PRESTAÇÃO DE SEVIÇOS, LDA ANGOLA, ClinCoord Research Center at Luanda Medical Center, CLINCOORD SERVICES, INC., Escola Superior de Tecnologia da Saúde de Lisboa, FUNDAÇAO CALOUSTE GULBENKIAN, FUNDACIÓN BANCARIA CAIXA D'ESTALVIS I PENSIONS DE BARCELONA

Country where clinical trial is conducted

Angola, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Institutional Collaborations	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
Primary	Maternal Mortality	Measuring the number of maternal mortalities up to 6 weeks postpartum.	2 years
Primary	Life Birth Related Events	The number of preterm births will be measured by the number of deliveries before 37 weeks gestational age.	2 years
Primary	Late Abortion Related Events	Measuring the number of unintentional abortions late in the pregnancy	2 years
Secondary	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
Secondary	Fetal Mortality Outcomes	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
Secondary	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