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Could earlier aspirin save lives in sickle cell pregnancies?

NCT ID NCT06417411

Disease control Sponsor: Instituto Nacional de Investigacao em Saude, Angola Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study looks at whether starting daily low-dose aspirin in the first trimester (weeks 1–12) is safer and more effective than starting in the second trimester (weeks 13–27) for pregnant women with sickle cell disease. Researchers will track maternal deaths, preterm births, and late miscarriages. The goal is to find the best timing to reduce serious pregnancy complications in this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aspirin 100 mg
What this could lead to
If starting aspirin earlier reduces complications, it could offer a simple, low-cost way to improve pregnancy outcomes in women with sickle cell disease.
What could go wrong
This is an early-phase study, so results may not be conclusive. Aspirin carries bleeding risks, and the benefit may be small or absent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

pregnancy disorder sickle cell disease preeclampsia prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pre-eclampsia Pregnancy complications Pregnancy related Sickle cell disease

Contacts and locations

Locations

  • Instituto Nacional de Investigação Em Saúde

    Luanda, Luanda Province, 00000, Angola

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