Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 12:38 PM
Study NCT ID:
NCT04368832
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
imPROving prenaTal carE During ConfinemenT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019114', 'term': 'Remote Consultation'}], 'ancestors': [{'id': 'D012017', 'term': 'Referral and Consultation'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score of perceived quality of prenatal care', 'timeFrame': 'Through study completion, an average of 3 months, ie either at the beginning of the second or the third trimester of pregnancy, or during immediate postpartum care', 'description': 'score obtained with the Quality of prenatal care questionnaire (QPCQ) as close as possible after release from containment'}], 'secondaryOutcomes': [{'measure': 'Level of stress during pregnancy', 'timeFrame': 'Through study completion, an average of 3 months, ie at the beginning of the second and the third trimester of pregnancy, and during immediate postpartum care', 'description': 'Perceived stress measured with Perceived Stress Scale-10 (PSS-10) scale'}, {'measure': 'level of health and digital literacy', 'timeFrame': 'Through study completion, an average of 3 months, ie at the beginning of the second and the third trimester of pregnancy, and during immediate postpartum care', 'description': 'level of health and digital literacy evaluated with Health Literacy Questionnaire (HLQ) and eHealth Literacy Questionnaire (eHLQ) questionnaire'}, {'measure': 'Obstetrical outcomes', 'timeFrame': 'Through study completion, an average of 6 months, ie at the end of postpartum care hospitalization', 'description': 'core set of outcomes for maternity care'}, {'measure': 'Characteristics of medical supervision during pregnancy', 'timeFrame': 'Through study completion, an average of 6 months, ie throughout the period of pregnancy', 'description': 'Number of remote, face-to-face or emergency consultations during pregnancy and requester of each consultation (patient or practitioner)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'containment measures'], 'conditions': ['Pregnancy Related', 'COVID']}, 'referencesModule': {'references': [{'pmid': '35882366', 'type': 'DERIVED', 'citation': 'Avercenc L, Ngueyon Sime W, Bertholdt C, Baumont S, Freitas AC, Morel O, Guillemin F, Ambroise Grandjean G. Improving prenatal care during lockdown: Comparing telehealth and in-person care for low-risk pregnant women in the PROTECT pilot study. J Gynecol Obstet Hum Reprod. 2022 Nov;51(9):102445. doi: 10.1016/j.jogoh.2022.102445. Epub 2022 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'This study is a non-randomized, quasi-experimental, monocentric study comparing two prenatal monitoring modes in low-risk pregnancy: including at least one remote consultation (phone or teleconsultation) versus face-to-face adapted to confinement. The quality of care perceived by the pregnant women were evaluated according to monitoring modes set up during the COVID-19 pandemic confinement period. The women included planned to give birth at the regional academic Maternity of Nancy, France.', 'detailedDescription': "The emergency confinement measures deployed by most industrialized countries governments to limit the impact of the coronavirus disease 2019(COVID-19) pandemic resulted in rapid and unpredictable changes in methods of obstetric monitoring. International and French government recommendations called for a reorganization of mandatory monitoring, particularly for low-risk pregnancies (limit the presence of the coparent during follow-up consultations and implement remote consultations). The potential impact of this reorganization on care perception, probably increased by the context of an unprecedented economic, social and health crisis, is unpredictable. In the absence of a previous event of comparable importance, it is impossible to anticipate differences in satisfaction with antenatal management and in stress level between women exposed to the two types of monitoring. Many factors can influence the perception of care quality, such as the socio-economic environment and the level of health literacy, that is, the individual's ability to find information on health, to understand and use this information to improve his own health or develop autonomy in health care system.\n\nThe objective of this study is to determine which type of monitoring is better perceived by pregnant women, the factors associated with this perception and the links with the level of knowledge and mastery of women regarding reproductive health and digital tools."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women with low obstetrical risk expecting to give birth in the Maternité régionale universitaire de Nancy, France.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant woman eligible for type A or A1 follow-up according to the French Health Authority "Haute Autorité de Santé" (HAS) (low-risk pregnancy)\n* Having consulted at least one practitioner (midwife or physician) during the COVID-19 national confinement period\n* Gestational age \\> 7 weeks of amenorrhea on 17th March 2020, at the beginning of the national confinement period in France\n* having received complete information on the organisation of this research and not opposed to participation and exploitation of her data\n* Childbirth expected in the regional academic Maternity of Nancy\n* Member of or beneficiary of a social security scheme\n* Speaking French and able to complete a self questionnaire or having the possibility of being assisted\n\nExclusion Criteria:\n\n* Not understanding French\n* Multiple pregnancy\n* Request for voluntary termination of pregnancy\n* Discovery or suspicion of congenital malformation\n* Under protection of justice, guardianship or trusteeship\n* Deprived of liberty by judicial or administrative decision\n* Undergoing psychiatric care under sections L. 3212-1 and L. 3213-1 of french law (hospitalization without consent).'}, 'identificationModule': {'nctId': 'NCT04368832', 'acronym': 'PROTECT', 'briefTitle': 'imPROving prenaTal carE During ConfinemenT', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'ImPROving prenaTal carE During ConfinemenT: Impact of Confinement on the Quality of Prenatal Care Perceived in Low-risk Pregnancy', 'orgStudyIdInfo': {'id': '2020-A01023-36'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group', 'description': 'During prenatal monitoring, at least one consultation by remote consultation (phone or teleconsultation)', 'interventionNames': ['Other: Remote consultation']}, {'label': 'Control group', 'description': 'Prenatal monitoring by face-to-face consultations adapted to confinement (absence of clinical signs or notion of travel, occupation, contact, clustering (TOCC), no attendant, limited movements inside the hospital and precautions of "droplet" and "contact" type)'}], 'interventions': [{'name': 'Remote consultation', 'type': 'OTHER', 'description': 'One or more consultation is conducted by phone or teleconsultation during prenatal monitoring', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54035', 'city': 'Nancy', 'country': 'France', 'facility': 'Maternité Régionale Universitaire de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Gaëlle Ambroise', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Nancy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mrs', 'investigatorFullName': 'Mme Gaëlle AMBROISE', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}