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Active, Not Recruiting

NCT Number: NCT06417411

LEARNER- Low dosE AspiRiN prEterm tRial (Angola)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Pregnancy Related Urogenital Diseases

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Instituto Nacional de Investigação Em Saúde

Luanda, Luanda Province, 00000, Angola

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin 100mg

Drug

Daily use of low dose aspirin.

Primary outcomes

  1. Maternal Mortality

    Time frame: 2 years

    Measuring the number of maternal mortalities up to 6 weeks postpartum.

  2. Life Birth Related Events

    Time frame: 2 years

    The number of preterm births will be measured by the number of deliveries before 37 weeks gestational age.

  3. Late Abortion Related Events

    Time frame: 2 years

    Measuring the number of unintentional abortions late in the pregnancy

Secondary outcomes

  1. Maternal Morbidity

    Time frame: 2 years

    hypertensive disorders, vaginal bleeding, antepartum hemorrhage, and postpartum hemorrhage, will be aggregated to determine the number of morbidity events related to the mother.

  2. Fetal Mortality Outcomes

    Time frame: 2 years

    fetal loss due to small gestational age, perinatal mortality, spontaneous abortion, and stillbirth, will be aggregated to quantify the number of fetal mortality events.

  3. Other Fetal Events

    Time frame: 2 years

    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.

Other outcomes

  1. Clinical Research Personnel Capacity Building

    Time frame: 2 years

    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. Institutional Collaborations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Investigacao em Saude, Angola

Other Gov

Collaborators

  • CLINCOORD PRESTAÇÃO DE SEVIÇOS, LDA ANGOLA
  • CLINCOORD SERVICES, INC.
  • Calouste Gulbenkian Foundation
  • ClinCoord Research Center at Luanda Medical Center
  • Escola Superior de Tecnologia da Saúde de Lisboa
  • FUNDACIÓN BANCARIA CAIXA D'ESTALVIS I PENSIONS DE BARCELONA

Registry information

Official study 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

Acronym: LEARNER

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 16, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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