Can blood transfusions protect pregnant women with sickle cell disease?

NCT ID NCT06979492

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving regular blood transfusions during pregnancy can reduce sickle cell complications and pregnancy-related problems in women with sickle cell disease. About 50 pregnant women will be randomly assigned to receive transfusions or standard care. The goal is to see if transfusions lower hospital visits and improve outcomes for both mother and baby.

What this could mean

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

Active substance
red blood cell transfusion
What this could lead to
If it works, this could establish a standard practice to prevent serious complications in pregnant women with sickle cell disease.
What could go wrong
This is a small Phase 4 trial with only 50 participants, so results may not apply to all. Transfusions carry risks like allergic reactions or iron overload.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Female * Diagnosis of SCD of any genotype (i.e., HbSS, HbSC, HbSβ thalassemia) * 18 Years and older * Currently pregnant at 6 weeks through 20 weeks of gestation. * Ability to understand the purposes and risks of the study and willingly give informed consent. * For participants with private health insurance, insurance pre-approval for blood transfusions Exclusion Criteria: * Currently on chronic transfusion therapy before pregnancy * Prior history of DHTR with hyperhemolysis * Red cell antibody history, which would prevent the provision of adequate red cell units to support chronic transfusions. * Unable or unwilling to receive blood transfusion for social, religious, or clinical reasons * Known current triplet pregnancy * Current diagnosis of major medical or psychiatric comorbidity, which in the randomizing clinician's opinion renders them unable to enter a clinical trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Grady Health System

    RECRUITING

    Atlanta, Georgia, 30303, United States

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