RecruitingPhase 1Phase 2NCT06417411

LEARNER- Low dosE AspiRiN prEterm tRial (Angola)

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


Sponsor

Instituto Nacional de Investigacao em Saude, Angola

Enrollment

450 participants

Start Date

Mar 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 15 Years

Inclusion Criteria3

  • \. 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.

Exclusion Criteria10

  • \. 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.

Interventions

DRUGAspirin 100mg

Daily use of low dose aspirin.


Locations(1)

Instituto Nacional de Investigação Em Saúde

Luanda, Angola

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NCT06417411


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