CompletedPhase 3

Oxygen Therapy and Pregnancy in Sickle Cell Disease

France178 participantsStarted 2016-10-05

Plain-language summary

The purpose of this study is to assess the efficiency of the preventive oxygen therapy on the occurrence of vaso-occlusive complications, which last more than 24 hours and require hospitalisation, in women with sickle cell disease.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Occurrence of at least one vaso-occlusive complication which last more than 24h

Timeframe: 30 days postpartum

Trial details

NCT IDNCT02813850

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-03

View on ClinicalTrials.gov More Sickle Cell Disease trials