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Nightly oxygen may ease sickle cell crisis in pregnancy

NCT ID NCT02813850

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving oxygen at home during the night could prevent severe pain episodes and other complications in pregnant women with sickle cell disease. 178 pregnant women took part, using an oxygen device for 4 hours each night. The goal was to see if this simple approach could reduce hospital visits and protect 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
oxygen therapy
What this could lead to
If it works, this could offer a simple, low-cost way to reduce dangerous pain crises and other complications during pregnancy for women with sickle cell disease.
What could go wrong
The trial is completed but results are not yet widely reported, so it is unclear if the oxygen therapy truly helped. Also, the treatment requires a device at home and may not be practical for everyone.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

178 people

The number who actually took part.

Started

Oct 2016

Finished

Aug 2022

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 to 50 years

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: * Pregnant women from 18 to 50 years old * Maximal term: 20SA * Patient with sickle cell disease * Consent form signed by the patient * Affiliated or beneficiary of a health insurance regimen and State Medical Aid. Exclusion Criteria: * Patients with transfusion restrictions * Patients whose house can not receive the device * Patients who have a weekly use of prophylactic oxygen therapy at home * Patients who don't understand the operating instructions \*Include patients with a doctor's prescription only. The portable oxygen concentrator will be removed from patients' home at the initiation visit prior to the overnight home oximetry test.

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Conditions

The condition(s) this trial relates to.

sickle cell disease

As listed by the trial registrant

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

Sickle cell disease

Contacts and locations

Locations

  • Hôpital Necker Enfants-Malades (Public Hospitals of Paris)

    Paris, Paris, 75015, France

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Other studies related to the condition(s) this trial covers.