LEARNER- Low dosE AspiRiN prEterm tRial (Angola)

Instituto Nacional de Investigacao em Saude, Angola

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Pre-Eclampsia; Pregnancy Complications; Pregnancy Related; Sickle Cell Disease

Treatments: Drug: Aspirin 100mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06417411

LEARNER

Details and patient eligibility

About

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.

Full 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)

Enrollment: 450 estimated patients

Sex: Female

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Aspirin in First trimester

Active Comparator group

Description:

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

Treatment:

Drug: Aspirin 100mg

Aspirin in Second trimester

Experimental group

Description:

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

Treatment:

Drug: Aspirin 100mg