LEARNER- Low dosE AspiRiN prEterm tRial (Angola) (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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Pregnancy Related; Sickle Cell Disease; Pre-Eclampsia
• Intervention / Treatment: Drug: Aspirin 100mg

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)

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: TATIANA GOMES, BA/BS/Pre-MD; Phone Number: +1 213 640 7052; Email: tatiana.gomes@clincoord.org
• Study Contact Backup: Name: HELENA TEIXEIRA, PhD; Phone Number: +55 071 991853687; Email: helena.pitangueira@clincoord.org

Study Locations

• Angola
  • Luanda, Angola, 00000
    • Recruiting
    • Instituto Nacional de Investigação Em Saúde
    • Contact: JOANA MORAIS, PhD; Phone Number: +244 934640266; Email: joana.morais@inis.gov.ao
    • Contact: TATIANA GOMES, PRE-MD; Phone Number: +1 213 640 7052; Email: tatiana.gomes@clincoord.org
    • Principal Investigator: JOANA MORAIS, PhD
    • Sub-Investigator: MAUER GONÇALVES, PhD
    • Sub-Investigator: MIGUEL BRITO, PhD
    • Sub-Investigator: HELENA TEIXEIRA, PhD
    • Sub-Investigator: TATIANA GOMES, PRE-MD
    • Principal Investigator: LIGIA ALVEZ, MD
    • Principal Investigator: MANUELA MENDES, MD
    • Sub-Investigator: CATARINA GINETE, PhD-Candidate
    • Sub-Investigator: PRECIOSA LOURENCO, MD
    • Sub-Investigator: FELIX ZAGE, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspirin in First trimester; Participants who will start the study medication (Aspirin) during the first trimester	Drug: Aspirin 100mg; Daily use of low dose aspirin.
Experimental: Aspirin in Second trimester; Participants who will start the study medication (Aspirin) during the second trimester	Drug: Aspirin 100mg; Daily use of low dose aspirin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Instituto Nacional de Investigacao em Saude, Angola
• Collaborators: FUNDAÇAO CALOUSTE GULBENKIAN; FUNDACIÓN BANCARIA CAIXA D'ESTALVIS I PENSIONS DE BARCELONA; CLINCOORD SERVICES, INC.; CLINCOORD PRESTAÇÃO DE SEVIÇOS, LDA ANGOLA; Escola Superior de Tecnologia da Saúde de Lisboa; ClinCoord Research Center at Luanda Medical Center
• Investigators: Principal Investigator: JOANA MORAIS, PhD, Instituto Nacional de Investigação Em Saúde; Study Director: TATIANA GOMES, BA/BS/Pre-MD, ClinCoord

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2024
• Primary Completion (Estimated): March 16, 2025
• Study Completion (Estimated): March 16, 2026

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 12, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Aspirin; Capacity Building; LEARNER; ANGOLA; Maternidade Lucrécia Paim; Hospital Materno Infantil Dr Manuel Pedro Azancot de Menezes
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Anemia, Sickle Cell; Eclampsia; Pre-Eclampsia; Pregnancy Complications; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: LEARNER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No