## Protocol Section
### Identification Module
**NCT ID:** NCT06417411

**Acronym:** LEARNER

**Brief Title:** LEARNER- Low dosE AspiRiN prEterm tRial (Angola)

**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

#### Organization Study ID Info
**ID:** LEARNER
#### Organization
**Class:** OTHER_GOV
**Full Name:** Instituto Nacional de Investigacao em Saude, Angola
### Status Module
#### Completion Date
**Date:** 2026-03-16

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03-16

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-16

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-02
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** FUNDACIÓN BANCARIA CAIXA D'ESTALVIS I PENSIONS DE BARCELONA

**Class:** UNKNOWN

**Name:** FUNDAÇAO CALOUSTE GULBENKIAN

**Class:** UNKNOWN

**Name:** CLINCOORD SERVICES, INC.

**Class:** UNKNOWN

**Name:** CLINCOORD PRESTAÇÃO DE SEVIÇOS, LDA ANGOLA

**Class:** OTHER

**Name:** Escola Superior de Tecnologia da Saúde de Lisboa

**Class:** UNKNOWN

**Name:** ClinCoord Research Center at Luanda Medical Center

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Instituto Nacional de Investigacao em Saude, Angola

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**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)

### Conditions Module

**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

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 450

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Aspirin 100mg

**Label:** Aspirin in First trimester

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Drug: Aspirin 100mg

**Label:** Aspirin in Second trimester

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Aspirin in First trimester

- Aspirin in Second trimester

**Description:** Daily use of low dose aspirin.

**Name:** Aspirin 100mg

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** 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.

**Measure:** Clinical Research Personnel Capacity Building

**Time Frame:** 2 years

**Description:** 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.

**Measure:** Institutional Collaborations

**Time Frame:** 2 years

#### Primary Outcomes

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

**Measure:** Maternal Mortality

**Time Frame:** 2 years

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

**Measure:** Life Birth Related Events

**Time Frame:** 2 years

**Description:** Measuring the number of unintentional abortions late in the pregnancy

**Measure:** Late Abortion Related Events

**Time Frame:** 2 years

#### Secondary Outcomes

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

**Measure:** Maternal Morbidity

**Time Frame:** 2 years

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

**Measure:** Fetal Mortality Outcomes

**Time Frame:** 2 years

**Description:** 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.

**Measure:** Other Fetal Events

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** 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.

**Gender Based:** True

**Gender Description:** Pregnant women

**Minimum Age:** 15 Years

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** tatiana.gomes@clincoord.org

**Name:** TATIANA GOMES, BA/BS/Pre-MD

**Phone:** +1 213 640 7052

**Role:** CONTACT

**Contact 2:**

**Email:** helena.pitangueira@clincoord.org

**Name:** HELENA TEIXEIRA, PhD

**Phone:** +55 071 991853687

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Luanda

**Contacts:**

***Contact 1:***

- **Email:** joana.morais@inis.gov.ao

- **Name:** JOANA MORAIS, PhD

- **Phone:** +244 934640266

- **Role:** CONTACT

***Contact 2:***

- **Email:** tatiana.gomes@clincoord.org

- **Name:** TATIANA GOMES, PRE-MD

- **Phone:** +1 213 640 7052

- **Role:** CONTACT

***Contact 3:***

- **Name:** JOANA MORAIS, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** MAUER GONÇALVES, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** MIGUEL BRITO, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** HELENA TEIXEIRA, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 7:***

- **Name:** TATIANA GOMES, PRE-MD

- **Role:** SUB_INVESTIGATOR

***Contact 8:***

- **Name:** LIGIA ALVEZ, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 9:***

- **Name:** MANUELA MENDES, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 10:***

- **Name:** CATARINA GINETE, PhD-Candidate

- **Role:** SUB_INVESTIGATOR

***Contact 11:***

- **Name:** PRECIOSA LOURENCO, MD

- **Role:** SUB_INVESTIGATOR

***Contact 12:***

- **Name:** FELIX ZAGE, MPH

- **Role:** SUB_INVESTIGATOR

**Country:** Angola

**Facility:** Instituto Nacional de Investigação Em Saúde

**Status:** RECRUITING

**Zip:** 00000

#### Overall Officials

**Official 1:**

**Affiliation:** INSTITUTO NACIONAL DE INVESTIGAÇÃO EM SAÚDE

**Name:** JOANA MORAIS, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** ClinCoord

**Name:** TATIANA GOMES, BA/BS/Pre-MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 31394941

**Citation:** 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

**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.

**PMID:** 29039130

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000000745

- Term: Anemia, Hemolytic, Congenital

- ID: D000000743

- Term: Anemia, Hemolytic

- ID: D000000740

- Term: Anemia

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000006453

- Term: Hemoglobinopathies

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000046110

- Term: Hypertension, Pregnancy-Induced

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7633

- Name: Eclampsia

- Relevance: HIGH

- As Found: Eclampsia

- ID: M14106

- Name: Pre-Eclampsia

- Relevance: HIGH

- As Found: Pre-Eclampsia

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M4085

- Name: Anemia, Sickle Cell

- Relevance: HIGH

- As Found: Sickle Cell Disease

- ID: M14127

- Name: Pregnancy Complications

- Relevance: HIGH

- As Found: Pregnancy Complications

- ID: M4070

- Name: Anemia

- Relevance: LOW

- As Found: Unknown

- ID: M9547

- Name: Hemolysis

- Relevance: LOW

- As Found: Unknown

- ID: M4073

- Name: Anemia, Hemolytic

- Relevance: LOW

- As Found: Unknown

- ID: M4075

- Name: Anemia, Hemolytic, Congenital

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9539

- Name: Hemoglobinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M25635

- Name: Hypertension, Pregnancy-Induced

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: T2019

- Name: Eclampsia

- Relevance: HIGH

- As Found: Eclampsia

- ID: T5229

- Name: Sickle Cell Anemia

- Relevance: HIGH

- As Found: Sickle Cell Disease

### Condition Browse Module - Meshes

- ID: D000004461

- Term: Eclampsia

- ID: D000011225

- Term: Pre-Eclampsia

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000000755

- Term: Anemia, Sickle Cell

### Intervention Browse Module - Ancestors

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000005343

- Term: Fibrinolytic Agents

- ID: D000050299

- Term: Fibrin Modulating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000010975

- Term: Platelet Aggregation Inhibitors

- ID: D000016861

- Term: Cyclooxygenase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000058633

- Term: Antipyretics

### Intervention Browse Module - Browse Branches

- Abbrev: Antipy

- Name: Antipyretics

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: FiAg

- Name: Fibrinolytic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4548

- Name: Aspirin

- Relevance: HIGH

- As Found: Grazoprevir

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8473

- Name: Fibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M13865

- Name: Platelet Aggregation Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19209

- Name: Cyclooxygenase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M29176

- Name: Antipyretics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001241

- Term: Aspirin

### Misc Info Module

- Version Holder: 2024-05-31
