Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-11 @ 6:31 AM
Study NCT ID:
NCT02642120
Status:
UNKNOWN
Last Update Posted:
2015-12-30
First Post:
2015-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dental Support and the Second Stage of Labor Among Multiparous Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-29', 'studyFirstSubmitDate': '2015-12-21', 'studyFirstSubmitQcDate': '2015-12-29', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of the second stage of labor.', 'timeFrame': '12 month', 'description': 'After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package.\n\nLabor follow up will be documented regularly including outcome. The use of the DSD will not affect the regular management of labor according to the routine standards of the delivery suite.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction (questionnaire)', 'timeFrame': '12 month', 'description': 'Following delivery, patients will be asked to complete a satisfaction questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Second Stage of Labor']}, 'descriptionModule': {'briefSummary': "To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage of labor and decreased the rate of obstetrical interventions, and if it's use alleviate pain.", 'detailedDescription': "Several studies have demonstrated that a dental support device (DSD) may increase the isometric strength of different muscle groups (1-7). A preliminary pilot study of 32 women in 2009 showed that DSD may shorten the second stage of labor among nulliparous women (8) by increasing the expulsive efforts of the parturient. The study hypothesis was that DSD may decrease the length of the second stage of labor and decrease the need for obstetrical interventions such as cesarean delivery or operative vaginal delivery.\n\nThe Laboraide™ is a DSD developed specifically for use during labor. It is an inert device located between the jaws and does not interfere with speaking, breathing or any other oral activity during labor. It is a single use device, and is not transferred between women. The investigators hypothesize that using this device can shorten the second stage of labor and decrease obstetrical intervention rate. The researchers will also investigate it's efficiency in pain management."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Singleton gestation\n2. Multiparous women\n3. Term gestation (\\>37+0/7 weeks)\n4. Signed written consent to participate in the study\n5. Maternal age 18-45 years\n6. Normal vital signs\n7. Noraml cardiotocography and biophysical profile at admission\n\nExclusion Criteria:\n\n1. Multiple gestation\n2. Nulliparous women\n3. preterm gestation (\\<37+0/7 weeks)\n4. Refusal to participate\n5. Maternal age \\<18 or \\> 45 years\n6. Normal vital signs\n7. Abnormal cardiotocography and biophysical profile at admission'}, 'identificationModule': {'nctId': 'NCT02642120', 'briefTitle': 'Dental Support and the Second Stage of Labor Among Multiparous Women', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Dental Support and the Second Stage of Labor Among Multiparous Women', 'orgStudyIdInfo': {'id': '0558-15- TLV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Receive Laboraide', 'description': 'After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package.', 'interventionNames': ['Device: Dental device "Laboraide"']}, {'type': 'NO_INTERVENTION', 'label': 'Do not receive Laboraide', 'description': 'After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the control group.'}], 'interventions': [{'name': 'Dental device "Laboraide"', 'type': 'DEVICE', 'description': 'After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package.\n\nLabor follow up will be documented regularly including outcome. The use of the DSD will not affect the regular management of labor according to the routine standards of the delivery suite. Following delivery, patients will be asked to complete a satisfaction questionnaire.', 'armGroupLabels': ['Receive Laboraide']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ariel many, professor', 'role': 'CONTACT', 'email': 'arielm@tlvmc.gov.il', 'phone': '052-4266954'}], 'overallOfficials': [{'name': 'Ariel many, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director General for R&D', 'investigatorFullName': 'michal roll', 'investigatorAffiliation': 'Tel-Aviv Sourasky Medical Center'}}}}