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Oxygen Therapy and Pregnancy in Sickle Cell Disease (DRO2G)

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ClinicalTrials.gov Identifier: NCT02813850
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Device: oxygen therapy Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Home-based Oxygen Therapy on Maternal and Fetal Complications, in Pregnant Women With Sickle Cell Disease. A Randomized Multi-center Trial.
Actual Study Start Date : October 5, 2016
Estimated Primary Completion Date : November 5, 2020
Estimated Study Completion Date : October 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
No Intervention: control
standard medical care
Experimental: oxygen therapy Device: oxygen therapy
Oxygen therapy early in the night (2L/min) during 4hours per days




Primary Outcome Measures :
  1. Occurrence of at least one vaso-occlusive complication which last more than 24h [ Time Frame: During pregnancy ]
    Painful vaso-occlusive episodes in bones, acute chest syndrome, ischemic stroke, cardiomyopathy, pulmonary hypertension, splenic and hepatic sequestration, death of the mother


Secondary Outcome Measures :
  1. Occurrence of at least one vaso-occlusive complication which last more than 24h [ Time Frame: 30 days postpartum ]
    Painful vaso-occlusive episodes in bones, acute chest syndrome, ischemic stroke, cardiomyopathy, pulmonary hypertension, splenic and hepatic sequestration, death of the mother

  2. Occurrence of pregnancy-induced hypertension, pre-eclampsia, eclampsia [ Time Frame: 20 months ]
  3. Occurence of hospitalisation because of premature delivery risk [ Time Frame: 20 months ]
  4. Occurence of late miscarriage [ Time Frame: 20 months ]
  5. Occurence of Preterm (<35SA) and very preterm ( from 26 to 32SA) [ Time Frame: 20 months ]
  6. Type of delivery (vaginal, active, caesarean) [ Time Frame: 20 months ]
  7. Number of days hospitalisation postpartum [ Time Frame: 20 months ]
  8. Occurence of Neonatal complications ( respiratory distress, analgesics withdrawal symptom) [ Time Frame: 20 months ]
  9. Number of days of hospitalisation for the newborn [ Time Frame: 20 months ]
  10. Number of days of hospitalisation in resuscitation unit for the newborn [ Time Frame: 20 months ]
  11. Newborn weight [ Time Frame: 20 months ]
  12. Newborn size [ Time Frame: 20 months ]
  13. Newborn head circumference [ Time Frame: 20 months ]
  14. Apgar score assess 1 min after birth [ Time Frame: 20 months ]
  15. Apgar score assess 5 min after birth [ Time Frame: 20 months ]
  16. Apgar score assess 10 min after birth [ Time Frame: 20 months ]
  17. Perinatal and neonatal death [ Time Frame: 20 months ]
  18. pH of of the newborn [ Time Frame: 20 months ]
  19. Lactate of of the newborn [ Time Frame: 20 months ]
  20. Number of days using painkiller (level II and III) during pregnancy [ Time Frame: 20 months ]
  21. Number of urgent consultation [ Time Frame: 20 months ]
  22. Number of days of hospitalisation and hospitalisation in intensive care during pregnancy [ Time Frame: 20 months ]
  23. Stage of pregnancy at the first transfusion [ Time Frame: 20 months ]
  24. Total volume of transfusion during pregnancy [ Time Frame: 20 months ]
  25. Way of transfusion: simple, bleeding-transfusion, erythrocytapheresis [ Time Frame: 20 months ]
  26. Maternal, fetal and newborn tolerability of home-based oxygen therapy during pregnancy [ Time Frame: 20 months ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813850


Contacts
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Contact: Laure JOSEPH, MD, PhD 00 33 1 44 49 52 74
Contact: Valérie JOLAINE, Master +33 1 42 19 28 79 valerie.jolaine@aphp.fr

Locations
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France
Hôpital Necker Enfants-Malades (Public Hospitals of Paris) Recruiting
Paris, France, 75015
Contact: Jean-Antoine RIBEIL, MD, PhD    +33 1 44 49 52 74    jean-antoine.ribeil@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Marina CAVAZZANA, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Jean-Antoine RIBEIL, MD,PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Alexandra BENACHI, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02813850     History of Changes
Other Study ID Numbers: P140030
2015-A01276-43 ( Registry Identifier: ID RCB )
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
sickle cell disease
oxygen therapy
pregnancy
pregnancy in sickle cell disease

Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn