Impact of Home-based Oxygen Therapy on Maternal and Fetal Complications, in Pregnant Women With Sickle Cell Disease. A Randomized Multi-center Trial.

Locations

1 France site

Age

18 to 50 Years

Phase

Phase 3

Study type

Interventional

Gender

Female

Interventions

Device

Compensation

Unknown

About the study

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.

participation requirements

– 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.

participation restrictions

– 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.

Locations

  • Paris, France, Hôpital Necker Enfants-Malades (Public Hospitals of Paris), 75015