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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Aspirin 100mg

Daily use of low dose aspirin.

Locations (1)

Instituto Nacional de Investigação Em Saúde
Luanda, Angola