Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-02-02 @ 9:31 AM
Study NCT ID:
NCT02813850
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2016-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxygen Therapy and Pregnancy in Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}], 'ancestors': [{'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2016-06-23', 'studyFirstSubmitQcDate': '2016-06-23', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of at least one vaso-occlusive complication which last more than 24h', 'timeFrame': '30 days postpartum', 'description': 'Painful vaso-occlusive episodes in bones, acute chest syndrome, ischemic stroke, cardiomyopathy, pulmonary hypertension, splenic and hepatic sequestration, death of the mother'}], 'secondaryOutcomes': [{'measure': 'Occurrence of at least one vaso-occlusive complication which last more than 24h', 'timeFrame': '30 days postpartum', 'description': 'Painful vaso-occlusive episodes in bones, acute chest syndrome, ischemic stroke, cardiomyopathy, pulmonary hypertension, splenic and hepatic sequestration, death of the mother'}, {'measure': 'Occurrence of pregnancy-induced hypertension, pre-eclampsia, eclampsia', 'timeFrame': '20 months'}, {'measure': 'Occurence of hospitalisation because of premature delivery risk', 'timeFrame': '20 months'}, {'measure': 'Occurence of late miscarriage', 'timeFrame': '20 months'}, {'measure': 'Occurence of Preterm (<35SA) and very preterm ( from 26 to 32SA)', 'timeFrame': '20 months'}, {'measure': 'Type of delivery (vaginal, active, caesarean)', 'timeFrame': '20 months'}, {'measure': 'Number of days hospitalisation postpartum', 'timeFrame': '20 months'}, {'measure': 'Occurence of Neonatal complications ( respiratory distress, analgesics withdrawal symptom)', 'timeFrame': '20 months'}, {'measure': 'Number of days of hospitalisation for the newborn', 'timeFrame': '20 months'}, {'measure': 'Number of days of hospitalisation in resuscitation unit for the newborn', 'timeFrame': '20 months'}, {'measure': 'Newborn weight', 'timeFrame': '20 months'}, {'measure': 'Newborn size', 'timeFrame': '20 months'}, {'measure': 'Newborn head circumference', 'timeFrame': '20 months'}, {'measure': 'Apgar score assess 1 min after birth', 'timeFrame': '20 months'}, {'measure': 'Apgar score assess 5 min after birth', 'timeFrame': '20 months'}, {'measure': 'Apgar score assess 10 min after birth', 'timeFrame': '20 months'}, {'measure': 'Perinatal and neonatal death', 'timeFrame': '20 months'}, {'measure': 'pH of of the newborn', 'timeFrame': '20 months'}, {'measure': 'Lactate of of the newborn', 'timeFrame': '20 months'}, {'measure': 'Number of days using painkiller (level II and III) during pregnancy', 'timeFrame': '20 months'}, {'measure': 'Number of urgent consultation', 'timeFrame': '20 months'}, {'measure': 'Number of days of hospitalisation and hospitalisation in intensive care during pregnancy', 'timeFrame': '20 months'}, {'measure': 'Stage of pregnancy at the first transfusion', 'timeFrame': '20 months'}, {'measure': 'Total volume of transfusion during pregnancy', 'timeFrame': '20 months'}, {'measure': 'Way of transfusion: simple, bleeding-transfusion, erythrocytapheresis', 'timeFrame': '20 months'}, {'measure': 'Maternal, fetal and newborn tolerability of home-based oxygen therapy during pregnancy', 'timeFrame': '20 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sickle cell disease', 'oxygen therapy', 'pregnancy', 'pregnancy in sickle cell disease'], 'conditions': ['Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Sickle cell disease (SCD) corresponds to a group of inherited disorders with clinical manifestations resulting from the biochemical consequences of a single-base substitution of valine by glutamic acid at position 6 of the ß-hemoglobin (Hb) subunit (HbA \\[ß6val\\] to HbS \\[ß6glu\\]). When the oxygen tension is low, the solubility of HbS falls and the molecules polymerize. In turn, the intracellular formation of HbS polymers results in red blood cell (RBC) sickling. The aggregation of sickle cells is responsible for the vaso-occlusive crises (VOCs) that characterize SCD.\n\nThanks to improvements in the management of SCD patients, over 95% of affected infants survive to adulthood. Pregnancy is a high-risk situation for women with sickle cell disease, especially in the third trimester, during delivery and in the post-partum period. Conversely sickle cell disease can lead to pregnancy complications for both mother and fetus since maternal-fetal mortality remains elevated.\n\nRBC transfusions and careful prevention of infections represent the only available treatments in this situation.\n\nThe complexity of this setting and the associated therapeutic strategy is further accentuated by the high frequency of post-transfusion side effects during SCD pregnancies, can indirectly affect the newborn by inducing hypoxia, and may ultimately prevent the woman from receiving further transfusions (RCOG, 2015) (Tuck et al, 1983). Post-transfusion complications constitute negative prognostic factors that affect both the mother's health and fetal development and thus increase the risk of premature death.\n\nAnother factor complicating the outcome of the pregnancy is the increase in oxygen demand in order to satisfy the increased metabolic requirements of the placenta and fetus. As the maternal oxygen reserve can be compromised during pregnancy for several reasons (such as the increased oxygen consumption, the SCD related anemia accentuated by the plasmatic increase), patients are particularly susceptible to hypoxemia - leading to the exacerbation of sickling events and SCD-related complications. (Hill \\& Pickinpaugh, 2008)(Thame et al, 2007)(Rathod et al, 2007a)(Cines et al, 1998)(Hassell, 2005)(Pantanowitz et al, 2000)(Rathod et al, 2007b) Moving from this observation, the first innovative approach introduced was the widespread use of prophylactic oxygen treatment at home. The rationale behind this change came from experiments on a murine model of SCD mice, in which a high-oxygen environment during pregnancy was associated with a lower prenatal fetal/maternal mortality rate (Ye et al, 2008). The absence of severe complications was also noticed in some women who could not be transfused (because of severe alloimmunization) and who were already receiving oxygen therapy at home before pregnancy.\n\nThen a preliminary retrospective study was performed to evaluate the clinical benefit of the widespread use of prophylactic oxygen treatment at home. It indicates that this innovative treatment is safe and seems to be associated with a significant decrease in the transfusion rate in SCD patients during pregnancy.\n\nThese findings are encouraging, but they are preliminary and bias have to be taken into account. These results have to be confirmed by a randomized trial.\n\nThe project aim is to assess preventive oxygen therapy impact on women with sickle cell disease, their fetal and their newborn. Firstly, investigators want to assess preventive home-based oxygen therapy efficacy for preventing vaso-occlusive complications which last 24 hours and require a hospitalization. Secondly, they want to assess oxygen therapy impact on prevention and characteristics of obstetrical complications, prevention of neonatal complications, fetal and newborn's characteristics, type of medical care, transfusion balance sheet, way of transfusion and maternal, fetal and newborn tolerability of home-based oxygen therapy during pregnancy.\n\nFor this they propose to analyze 200 pregnant SCD women. 100 women in the first arm with standard medical care. 100 women in the second arm who will have home-based oxygen therapy early at night.\n\nThis study will be performed in 9 French hospitals. Blood samples of SCD women and blood cord will be drawn to monitor red cell adherence protein expression and function and their mechanic and adhesive properties."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant women from 18 to 50 years old\n* Maximal term: 20SA\n* Patient with sickle cell disease\n* Consent form signed by the patient\n* Affiliated or beneficiary of a health insurance regimen and State Medical Aid.\n\nExclusion Criteria:\n\n* Patients with transfusion restrictions\n* Patients whose house can not receive the device\n* Patients who have a weekly use of prophylactic oxygen therapy at home\n* 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."}, 'identificationModule': {'nctId': 'NCT02813850', 'acronym': 'DRO2G', 'briefTitle': 'Oxygen Therapy and Pregnancy in Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of Home-based Oxygen Therapy on Maternal and Fetal Complications, in Pregnant Women With Sickle Cell Disease. A Randomized Multi-center Trial.', 'orgStudyIdInfo': {'id': 'P140030'}, 'secondaryIdInfos': [{'id': '2015-A01276-43', 'type': 'REGISTRY', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'standard medical care'}, {'type': 'EXPERIMENTAL', 'label': 'oxygen therapy', 'interventionNames': ['Device: oxygen therapy']}], 'interventions': [{'name': 'oxygen therapy', 'type': 'DEVICE', 'description': 'Oxygen therapy early in the night (2L/min) during 4hours per days', 'armGroupLabels': ['oxygen therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker Enfants-Malades (Public Hospitals of Paris)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Alexandra BENACHI, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Laure JOSEPH, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Marina CAVAZZANA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}