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Sickle Cell DiseasePhase 1/2LEARNERNCT06417411

LEARNER- Low dosE AspiRiN prEterm tRial (Angola)

A Phase 1/2 study testing Aspirin 100mg in people with Sickle Cell Disease and Pregnancy Related, run by Instituto Nacional de Investigacao em Saude, Angola at 1 site in Angola.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 15 years and older, women only
What is being tested?
Aspirin 100mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteAngola
Study dates
16 Mar 2024to 16 Oct 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Angola1 site

  • Instituto Nacional de Investigação Em Saúde

    Luanda, Luanda Province, 00000

About this study

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

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.

Read the 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)

Being tested
Aspirin 100mg
Keywords
LEARNER, ANGOLA, Maternidade Lucrécia Paim, Hospital Materno Infantil Dr Manuel Pedro Azancot de Menezes, Aspirin, Capacity Building
Medical subject headings
Anemia, Sickle Cell, Pregnancy Complications, Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aspirin 100mgDrug

    Daily use of low dose aspirin.

Study groups in NCT06417411
Study groupRoleWhat they receive
Aspirin in First trimesterActive comparatorParticipants who will start the study medication (Aspirin) during the first trimester
Receives: Drug: Aspirin 100mg
Aspirin in Second trimesterExperimentalParticipants who will start the study medication (Aspirin) during the second trimester
Receives: Drug: Aspirin 100mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal Mortality

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

    Measured: 2 years

  2. Life Birth Related Events

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

    Measured: 2 years

  3. Late Abortion Related Events

    Measuring the number of unintentional abortions late in the pregnancy

    Measured: 2 years

Secondary outcomes (3)

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start16 Mar 2024
  3. Primary completion30 Mar 2026
  4. Study completion16 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06417411
Sponsor's protocol ID
LEARNER
Acronym
LEARNER
Status last verified
Jul 2026
First submitted
2 May 2024
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31394941

  • 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.

    PubMed 34389570

  • 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.

    PubMed 29039130

  • Brito M, Ginete C, Gomes T, Pitangueira H, Mendes M, Furtado A, Alves L, Simao F, Goncalves M, Morais J. 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 - study protocol. Contemp Clin Trials Commun. 2026 May 18;51:101649. doi: 10.1016/j.conctc.2026.101649. eCollection 2026 Jun.

    PubMed 42220645

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Aspirin 100mg in people with Sickle Cell Disease and Pregnancy Related, run by Instituto Nacional de Investigacao em Saude, Angola at 1 site in Angola.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Angola. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal Mortality (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06417411, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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LEARNER- Low dosE AspiRiN prEterm tRial (Angola) | AzTrials