Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-31 @ 12:45 PM
Study NCT ID:
NCT03202550
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2017-06-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Sedation During Cervical Dilator Placement
Sponsor:
Organization:
Raw JSON
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100=worst pain ever)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants.'}, {'type': 'SECONDARY', 'title': 'Pain Score After First Dilator Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm', 'description': 'Two oral placebo pills (microcrystalline cellulose capsules)\n\nPlacebo Comparator: Placebo oral pills'}, {'id': 'OG001', 'title': 'Active Drug Arm: Lorazepam and Oxycodone', 'description': '1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)\n\nOxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '56'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'pain score given immediately after first dilator placed, up to 1 minute', 'description': 'Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants.'}, {'type': 'SECONDARY', 'title': 'Pain Score 15 Minutes After Last Dilator Placed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm', 'description': 'Two oral placebo pills (microcrystalline cellulose capsules)\n\nPlacebo Comparator: Placebo oral pills'}, {'id': 'OG001', 'title': 'Active Drug Arm: Lorazepam and Oxycodone', 'description': '1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)\n\nOxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '44'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed up to 45 minutes after last dilator placed', 'description': 'Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever). This was to be assessed at 15 minutes after last dilator is placed. Some participants had this assessment done up to 45 minutes after last dilator was placed because it could not be done at 15 minutes (some were being attended to by a nurse at the 15 minutes mark).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Arm', 'description': 'Two oral placebo pills (microcrystalline cellulose capsules)\n\nPlacebo Comparator: Placebo oral pills'}, {'id': 'FG001', 'title': 'Active Drug Arm: Lorazepam and Oxycodone', 'description': '1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)\n\nOxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Three participants who were enrolled but did not receive the intervention had either chosen not to proceed further with the study or were not able to swallow the study drugs.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Arm', 'description': 'Two oral placebo pills (microcrystalline cellulose capsules)\n\nPlacebo Comparator: Placebo oral pills'}, {'id': 'BG001', 'title': 'Active Drug Arm: Lorazepam and Oxycodone', 'description': '1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)\n\nOxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-17', 'size': 288984, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-20T15:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The participant, provider, and nursing staff will be blinded to the intervention. The pharmacy will prepare the treatment drugs and placebos.. Randomization will be stratified by gestational age (\\>= 20 weeks or \\<20 weeks) and the randomization allocation sequence will be computer-generated with a random number generator by a statistician. The pharmacist will be aware of the randomization sequence and will dispense the drugs as appropriate, while keeping track of which arms participants were randomized to.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2017-06-27', 'resultsFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2017-06-27', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-20', 'studyFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device', 'timeFrame': 'Immediately after the last dilator is placed, up to 1 minute', 'description': 'Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Desired Number of Dilators Inserted', 'timeFrame': 'After speculum removed, up to 30 minutes', 'description': 'Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms.'}, {'measure': 'Baseline Pain Score Before Drugs Were Administered', 'timeFrame': 'pain score given prior to administration of study drugs, up to 1 minute', 'description': 'Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)'}, {'measure': 'Pain Score Before Speculum Placement', 'timeFrame': 'pain score given before specula placed, up to 1 minute', 'description': 'Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)'}, {'measure': 'Pain Score After Speculum Placement', 'timeFrame': 'pain score given at time of speculum placement, up to 1 minute', 'description': 'Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)'}, {'measure': 'Pain Score at Tenaculum Placement', 'timeFrame': 'Immediately scored at time of tenacula placement, up to 1 minute', 'description': 'Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)'}, {'measure': 'Pain Score During Paracervical Block', 'timeFrame': 'pain score given at time of paracervical block administration, up to 1 minute', 'description': 'Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)'}, {'measure': 'Pain Score After First Dilator Placement', 'timeFrame': 'pain score given immediately after first dilator placed, up to 1 minute', 'description': 'Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)'}, {'measure': 'Pain Score 15 Minutes After Last Dilator Placed', 'timeFrame': 'Assessed up to 45 minutes after last dilator placed', 'description': 'Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever). This was to be assessed at 15 minutes after last dilator is placed. Some participants had this assessment done up to 45 minutes after last dilator was placed because it could not be done at 15 minutes (some were being attended to by a nurse at the 15 minutes mark).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral Sedation', 'Lorazepam', 'Oxycodone'], 'conditions': ['Oral Sedation and Cervical Dilator Pain']}, 'referencesModule': {'references': [{'pmid': '25139724', 'type': 'BACKGROUND', 'citation': 'Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.'}, {'type': 'BACKGROUND', 'citation': 'Soon, R. T., M.; Salcedo. J.; Kaneshiro, B., Paracervical block to decrease pain with second-trimester laminaria insertion: a randomized controlled trial. Contraception 2016, 94 (4), 389.'}, {'pmid': '11980742', 'type': 'BACKGROUND', 'citation': 'Wong CY, Ng EH, Ngai SW, Ho PC. A randomized, double blind, placebo-controlled study to investigate the use of conscious sedation in conjunction with paracervical block for reducing pain in termination of first trimester pregnancy by suction evacuation. Hum Reprod. 2002 May;17(5):1222-5. doi: 10.1093/humrep/17.5.1222.'}, {'pmid': '12618257', 'type': 'BACKGROUND', 'citation': 'Wiebe E, Podhradsky L, Dijak V. The effect of lorazepam on pain and anxiety in abortion. Contraception. 2003 Mar;67(3):219-21. doi: 10.1016/s0010-7824(02)00516-4.'}]}, 'descriptionModule': {'briefSummary': 'This will be a randomized, double-blind, placebo-controlled trial involving 2 arms. It will be comparing the effects of placebo compared to 1 mg oral lorazepam/5 mg oral oxycodone on pain scores during cervical dilator placement prior to dilation and evacuation (D\\&E).', 'detailedDescription': "Potential participants will be first introduced to the study via routine intake call. Participants will be identified at the participant's office visits to the Johns Hopkins' Women's Center for Family Planning. If a patient desires D\\&E for a second trimester pregnancy, the patient will first receive standard counseling. Only after providing written informed consent for the procedure will the patients be screened for eligibility in the study. If the patient is eligible the participant will be asked by a member of the research team if the patient is interested in participating. If the patient is, the study will be explained to the participant and written consent will be obtained after participant is given the opportunity to have all questions answered.\n\nThe study is randomized, double-blind, placebo-controlled trial involving 2 arms. Participants will first complete a survey to collect demographic data.\n\nParticipants in both arms will receive the institution's current standard analgesia for cervical dilator placement. In addition to this standard regimen, participants will be randomized to receive either: (1) a dose of two oral placebo pills, or (2) 1mg of oral lorazepam with 5 mg of oral oxycodone prior to cervical dilator placement."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-50 years\n* English speaking\n* With an intrauterine pregnancy (either viable or non-viable) between the gestational ages of 17w0d and 23w6d\n* Have a support person present with participant\n* Have a cell phone capable of text messaging (optional)\n\nExclusion Criteria:\n\n* Non-English-speaking\n* Taking a daily benzodiazepine or opiate\n* Have a known allergy or contraindication to NSAIDs, opiates, or benzodiazepines'}, 'identificationModule': {'nctId': 'NCT03202550', 'acronym': 'OSDI', 'briefTitle': 'Oral Sedation During Cervical Dilator Placement', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB00117627'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Two oral placebo pills (microcrystalline cellulose capsules)', 'interventionNames': ['Drug: Placebo Comparator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Drug Arm: Lorazepam and Oxycodone', 'description': '1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)', 'interventionNames': ['Drug: Oxycodone and Lorazepam (Active Comparator)']}], 'interventions': [{'name': 'Oxycodone and Lorazepam (Active Comparator)', 'type': 'DRUG', 'otherNames': ['Oral Oxycodone', 'Oral Lorazepam', 'Ativan', 'OxyIR', 'Roxicodone'], 'description': 'Oxycodone and Lorazepam', 'armGroupLabels': ['Active Drug Arm: Lorazepam and Oxycodone']}, {'name': 'Placebo Comparator', 'type': 'DRUG', 'description': 'Placebo oral pills', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': "Johns Hopkins' Women's Center for Family Planning", 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Carolyn Sufrin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Jessica K Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The study plans to share placebo data (without PHI) with colleagues at University of California Davis at the end of the study. A Memorandum of Understanding will be created prior to sharing (MOU) and data will be shared across a secure server.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}