Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT03795857
Status:
COMPLETED
Last Update Posted:
2019-08-29
First Post:
2019-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antenatal Palliative Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005313', 'term': 'Fetal Death'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-28', 'studyFirstSubmitDate': '2019-01-02', 'studyFirstSubmitQcDate': '2019-01-03', 'lastUpdatePostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of the pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis', 'timeFrame': 'About 1 hour and 30 minutes', 'description': 'The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fetal Death', 'Fetal Anomaly']}, 'descriptionModule': {'briefSummary': "In France, according to current legislation, termination of pregnancy could be performed without any upper gestational age limit, if there is a strong probability that the fetus will be affected by a particularly severe and incurable disease. When there is a lethal fetal diagnosis most of parents wish to terminate their pregnancy. However, and despite some medical resistance a few of them do wish to continue pregnancy. In these situations, palliative care seems to be a good way to prepare to welcome the child and surround him until death.\n\nThe aim of the study is to describe parents' experience for a better understanding and a better care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will focus on couples who have been diagnosed with lethal fetal pathology and who have chosen to continue the pregnancy for a birth in palliative care.\n\nThe death of the child may have occurred in utero or after birth.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The woman must be between the ages of 18 and 50 and the adult,\n* Participants must have received the information and not have objected to participating in the study,\n* the lethal / adverse short-term prognosis of the fetal pathology must have been confirmed by a committee of experts (CPDPN),\n* The choice to continue the pregnancy should have been clearly expressed,\n* The birth of the child should not be older than 24 months.\n* The child's death must be more than 6 months old (or not have occurred)\n\nExclusion Criteria:\n\n* Non-mastery of the French language,\n* Measure of legal protection of one of the members of the couple (guardianship, trusteeship, ...),\n* Severe psychiatric or neurological disorders inducing significant cognitive impairment."}, 'identificationModule': {'nctId': 'NCT03795857', 'acronym': 'SPAN', 'briefTitle': 'Antenatal Palliative Care', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Lethal Fetal Abnormality : the Experience of Pregnancy by Parents Who Have Chosen to Carry to Term With Palliative Care.', 'orgStudyIdInfo': {'id': '69HCL18_0371'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Semi-structured interviews', 'type': 'BEHAVIORAL', 'description': 'The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Équipe de psychopathologie périnatale - Service de psychopathologie du développement - Centre Hospitalier Femme-Mère-Enfant - Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Service de gynécologie obstétrique - Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Service de gynécologie-obstétrique - Centre hospitalier Lyon sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}