Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-05 @ 8:41 PM
Study NCT ID:
NCT03045705
Status:
WITHDRAWN
Last Update Posted:
2020-09-16
First Post:
2017-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Problem with patient recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-12', 'studyFirstSubmitDate': '2017-02-05', 'studyFirstSubmitQcDate': '2017-02-05', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale at the time of epidural anesthesia', 'timeFrame': 'Up to 3 days from admission.', 'description': 'Visual analogue scale as reflected by the participant at the time of choice to receive epidural anesthesia.'}], 'secondaryOutcomes': [{'measure': 'Visual analogue scale at the time of first medical analgesia', 'timeFrame': 'Up to 3 days from admission.', 'description': 'Visual analogue scale as reflected by the participant at the time of choice to receive the first modality of analgesia.'}, {'measure': 'Analgesia during labor', 'timeFrame': 'Up to 3 days from admission.', 'description': 'Which modalities of analgesia the participant took during labor'}, {'measure': 'Cervical dilatation at the time of epidural anesthesia', 'timeFrame': 'Up to 3 days from admission.', 'description': 'Cervical dilatation at the time of choice to receive epidural anesthesia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'In the current study the investigators wish to evaluate the effect the doctors and midwives in the delivery room have on the timing and modality of analgesia chosen by the participants. The participants will be randomly divided into 2 groups. Both groups will be advised of the different modalities of analgesia available during labor. One group will be managed in the delivery room the same as if not part of the study, meaning the doctors and midwives will treat the participants the way they usually do regarding analgesia. The second group of participants will not be asked by the doctors and midwives about analgesia at all but will be able to receive analgesia by a modality of choice at the timing of choice.', 'detailedDescription': "After explaining to the participants the study and having signed a confirmed consent, participants will receive an extensive explanation regarding the different modalities of analgesia available during labor. After the explanations the participants will be randomly divided into 2 groups:\n\n1. Routine management-doctors and midwives will treat the participants the way they usually do regarding analgesia including frequent inquiries about wishes for analgesia.\n2. Interventional management-participants will not be asked by the doctors and midwives about analgesia at all during labor but will be able to receive analgesia by a modality of choice at the timing of choice after being advised by the medical team.\n\nAfter delivery, participants will fill a questionnaire regarding the experience of labor in general and the relevance of analgesia during labor including the effect the medical team may have had on decision making during labor.\n\nMedical information regarding visual analogue scale (VAS), analgesia modality, cervical conditions, parity etc. will be extracted from patients' electronic files."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women planned for vaginal delivery.\n\nExclusion Criteria:\n\n* Women planned for cesarean section.\n* Women with comorbidities related to pain that may exacerbate during labor.'}, 'identificationModule': {'nctId': 'NCT03045705', 'briefTitle': 'Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.', 'orgStudyIdInfo': {'id': '0071-17-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Labor+routine pain management', 'description': 'Women that will be treated by the medical team in the delivery room as if not part of a study regarding pain management.', 'interventionNames': ['Behavioral: Routine pain management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Labor+experimental pain management', 'description': 'Women that will not be asked at all by the medical team in the delivery room regarding analgesia during labor but will be able to receive analgesia at wish at the time of choice.', 'interventionNames': ['Behavioral: No inquiry regarding analgesia']}], 'interventions': [{'name': 'Routine pain management', 'type': 'BEHAVIORAL', 'description': "Women that will be asked according to the routine management regarding pain management during labor, meaning frequent inquiries regarding the woman's wishes to receive analgesia by the medical team.", 'armGroupLabels': ['Labor+routine pain management']}, {'name': 'No inquiry regarding analgesia', 'type': 'BEHAVIORAL', 'description': 'women will not be asked about analgesia during labor by the medical team, but will be able to receive the modality of choice at the time of choice.', 'armGroupLabels': ['Labor+experimental pain management']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam health care campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Roy Lauterbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary investigator', 'investigatorFullName': 'ROY LAUTERBACH MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}