Low dose aspirin use in pregnant women with sickle cell disease
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 testing whether taking a low dose of aspirin during pregnancy can help improve outcomes for women with sickle cell disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 15 Years and up |
| Sex | Female |
| Sponsor | Instituto Nacional de Investigacao em Saude, Angola Government |
| Locations | 1 site (Luanda) |
| Trial ID | NCT06417411 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effects of daily low dose (100 mg) aspirin in pregnant women diagnosed with sickle cell disease. It is a prospective, randomized controlled trial involving 450 participants from two maternity hospitals in Angola. Participants will be randomly assigned to start aspirin either in the first trimester or the second trimester of their pregnancy, and will continue until week 36 or delivery. The study aims to determine the optimal timing for aspirin administration to improve pregnancy outcomes.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 15 years and older with a confirmed diagnosis of sickle cell disease.
Not a fit: Patients in the third trimester or those with certain comorbidities such as HIV, diabetes, or chronic hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve pregnancy outcomes for women with sickle cell disease.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have shown potential benefits of aspirin in pregnancy-related complications.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Luanda
- Instituto Nacional de Investigação Em Saúde — Luanda, Angola (Recruiting)
Study contacts
- Principal investigator: JOANA MORAIS, PhD — Instituto Nacional de Investigação Em Saúde
- Study coordinator: TATIANA GOMES, BA/BS/Pre-MD
- Email: tatiana.gomes@clincoord.org
- Phone: +1 213 640 7052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.