LEARNER- Low dosE AspiRiN prEterm tRial (Angola)

NCT06417411 | Recruiting Phase 1 DMC

• 1 other identifier: LEARNER
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Maternal Morbidity

  2 years

• Fetal Mortality Outcomes

  2 years

• Other Fetal Events

  2 years

Other Outcomes (2)

• Clinical Research Personnel Capacity Building

  2 years

• Institutional Collaborations

  2 years

Study Arms (2)

Aspirin in First trimester

ACTIVE COMPARATOR

Participants who will start the study medication (Aspirin) during the first trimester

Drug: Aspirin 100mg

Aspirin in Second trimester

EXPERIMENTAL

Participants who will start the study medication (Aspirin) during the second trimester

Drug: Aspirin 100mg

Interventions

Aspirin 100mg DRUG

Daily use of low dose aspirin.

Aspirin in First trimester; Aspirin in Second trimester

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Pregnant women with Sickle Cell Disease 15 years old and older
• \. 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
• \. Willing to attend the regular consultations, and consent to take part in the study.

You may not qualify if:

• \. Pregnant women with Sickle Cell Disease in the third trimester (after week 27)
• \. HIV infection
• \. Diabetes mellitus
• \. Chronic hypertension
• \. Liver disease measured by laboratory indication being 3 times above the upper limit of normal
• \. Sickle nephropathy
• \. Multiple pregnancies
• \. Hypersensitivity to aspirin
• \. History of blood transfusion in the last 3 months
• Those who did not consent to participate in the study.

Sponsors & Collaborators

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

Study Sites (1)

Instituto Nacional de Investigação Em Saúde

Luanda, 00000, Angola

RECRUITING

Related Publications (3)

• 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.

  PMID: 31394941 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.

  PMID: 34389570 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.

  PMID: 29039130 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Pregnancy Complications; Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• JOANA MORAIS, PhD

  INSTITUTO NACIONAL DE INVESTIGAÇÃO EM SAÚDE

  PRINCIPAL INVESTIGATOR

• TATIANA GOMES, BA/BS/Pre-MD

  ClinCoord

  STUDY DIRECTOR

Central Study Contacts

TATIANA GOMES, BA/BS/Pre-MD

CONTACT

+1 213 640 7052; tatiana.gomes@clincoord.org

HELENA TEIXEIRA, PhD

CONTACT

+55 071 991853687; helena.pitangueira@clincoord.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 16, 2024
• Study Start: March 16, 2024
• Primary Completion: March 16, 2025
• Study Completion: March 16, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AN (1)