Oxygen Therapy and Pregnancy in Sickle Cell Disease

NCT02813850 | Completed Phase 3

• 2 other identifiers: P1400302015-A01276-43
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sickle Cell Disease

Keywords

sickle cell disease; oxygen therapy; pregnancy; pregnancy in sickle cell disease

Outcome Measures

Primary Outcomes (1)

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

  Painful vaso-occlusive episodes in bones, acute chest syndrome, ischemic stroke, cardiomyopathy, pulmonary hypertension, splenic and hepatic sequestration, death of the mother

  30 days postpartum

Secondary Outcomes (26)

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

  30 days postpartum

• Occurrence of pregnancy-induced hypertension, pre-eclampsia, eclampsia

  20 months

• Occurence of hospitalisation because of premature delivery risk

  20 months

• Occurence of late miscarriage

  20 months

• Occurence of Preterm (<35SA) and very preterm ( from 26 to 32SA)

  20 months

Study Arms (2)

control

NO INTERVENTION

standard medical care

oxygen therapy

EXPERIMENTAL

Device: oxygen therapy

Interventions

oxygen therapy DEVICE

Oxygen therapy early in the night (2L/min) during 4hours per days

oxygen therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker Enfants-Malades (Public Hospitals of Paris)

Paris, Paris, 75015, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Study Officials

• Alexandra BENACHI, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Laure JOSEPH, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Marina CAVAZZANA, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 27, 2016
• Study Start: October 5, 2016
• Primary Completion: December 3, 2021
• Study Completion: August 12, 2022
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)