Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-02 @ 12:50 AM
Study NCT ID:
NCT03242356
Status:
COMPLETED
Last Update Posted:
2018-04-13
First Post:
2017-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Feeding During Established Labor at Our Institution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2017-08-07', 'lastUpdatePostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of parturients who declared to have ingested clear fluid during the labor.', 'timeFrame': 'The survey will be completed within 2 hours following the delivery'}], 'secondaryOutcomes': [{'measure': 'Determine the instructions given by health professionals, their spontaneous or non-spontaneous character and the information related to the given fast, according to the parturient', 'timeFrame': 'The survey will be completed within 2 hours following the delivery', 'description': 'Determine the instructions given by health professionals, whether they are spontaneous or not'}, {'measure': 'Specify the type of liquid ingested (water or sweet liquid) and its volume', 'timeFrame': 'The survey will be completed within 2 hours following the delivery', 'description': 'Nature and volume of liquids ingested'}, {'measure': 'Specify the frequency of ingestion of solid foods during labor', 'timeFrame': 'The survey will be completed within 2 hours following the delivery', 'description': 'Nature and quantity of ingested solids'}, {'measure': 'Assess the degree of discomfort associated with thirst that was felt during labor', 'timeFrame': 'The survey will be completed within 2 hours following the delivery', 'description': 'Degree of discomfort related to thirst on a simple numeric scale (0: no discomfort at 10: very uncomfortable)'}, {'measure': 'Assess the degree of discomfort associated with hunger that was felt during labor', 'timeFrame': 'The survey will be completed within 2 hours following the delivery', 'description': 'Degree of discomfort related to hunger on a simple numeric scale (0: no discomfort at 10: very uncomfortable)'}, {'measure': "Evaluate women's satisfaction with the fasting instructions received", 'timeFrame': 'The survey will be completed within 2 hours following the delivery', 'description': 'Satisfaction with fasting instructions given on a simple numerical scale (0: very high dissatisfaction, 10: maximum satisfaction)'}, {'measure': 'Determine if nausea and vomiting are more common in women who have ingested fluids during labor', 'timeFrame': 'The survey will be completed within 2 hours following the delivery', 'description': 'Incidence of at least one episode of nausea and vomiting during labor'}, {'measure': 'Analyze the factors associated with fasting during work and their concordance with the French recommendations on fasting during labor', 'timeFrame': 'The survey will be completed within 2 hours following the delivery', 'description': "Analysis of independent risk factors for the patient's strict fasting during labor"}, {'measure': 'Indicate the total duration of fast and solid fasting before birth', 'timeFrame': 'The survey will be completed within 2 hours following the delivery', 'description': 'Total duration of liquid fasting and solids preceding birth'}, {'measure': 'Compare fasting instructions received by patients and practices reported by professionals', 'timeFrame': 'The survey will be completed within 2 hours following the delivery', 'description': 'Fasting instructions received by patients and practices reported by professionals obtained during a practice survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor']}, 'descriptionModule': {'briefSummary': 'Current French guidelines allow oral intake of clear fluid in women in established labor under epidural analgesia. To date, no study assessed how these guidelines are followed in clinical practice. This study aims to assess the current practices as to the fasting during the labor at our institution, while assessing the experience and the expectations of the parturients (level of comfort or discomfort related to fasting).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult women who were in labor in our hospital interviewed within 2 hours after vaginal delivery or cesarean section decided during the labor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult woman who has been in labor in our hospital\n\nExclusion Criteria:\n\n* Patient refusal\n* Elective cesarean section, or emergency cesarean section in a woman not in labor\n* Intrauterine fetal death\n* Therapeutic abortion\n* Patient consent not available (for example, in case of severe post-partum hemorrhage)'}, 'identificationModule': {'nctId': 'NCT03242356', 'briefTitle': 'Oral Feeding During Established Labor at Our Institution', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Oral Feeding During Established Labor. Current Practices in the Obstetric Department of the Femme Mère Enfant Hospital (Lyon, France)', 'orgStudyIdInfo': {'id': '69HCL17_0454'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire to assess of the application of the current French guidelines as to fasting during labor.', 'type': 'OTHER', 'description': 'Questionnaire focuses on :\n\n* oral intake of clear fluid during the labor\n* oral intake of solid meal during the labor\n* fasting duration for solid and liquids\n* instruction received as to fasting during labor, nature of these instructions, and who given the instruction (midwife, nurse anesthetist, …)\n* discomfort related to thirst during labor\n* discomfort related to hunger during labor\n\nWe will also record several medical data as to the course of pregnancy and delivery, analgesia technique, history and characteristics of the parturient.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'hopital Femme Mère Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}