Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT02824302
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2016-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3 Simple Questions to Predict Labor Pain and Epidural Analgesia Use in Parturients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-10', 'studyFirstSubmitDate': '2016-05-13', 'studyFirstSubmitQcDate': '2016-06-30', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve (AUC)', 'timeFrame': 'this outcome will measure the pain scores during labour from the start of epidural insertion until its discontinued.', 'description': 'this outcome will be measured at day 1 of delivery'}], 'secondaryOutcomes': [{'measure': 'Time from onset of labor to epidural analgesia', 'timeFrame': 'minutes > 30 minutes'}, {'measure': 'Cervical dilatation at the time of request(cm)', 'timeFrame': 'hours (>1 hour)'}, {'measure': 'Pain score at the time of request of labor analgesia', 'timeFrame': 'VAS (1-10)'}, {'measure': 'Duration labor', 'timeFrame': 'hours (> 1 hour)'}, {'measure': 'Number of epidural boluses', 'timeFrame': 'hours (> 1 hour)'}, {'measure': 'Patient comfort during labor (1-5)', 'timeFrame': 'hours (>1 hour)'}, {'measure': 'Pain VAS during Epidural insertion (0-10)', 'timeFrame': 'hours (> 1 hour)'}, {'measure': 'Patient satisfaction with epidural analgesia', 'timeFrame': 'hours ( >1 hour)'}, {'measure': 'Mode of delivery', 'timeFrame': 'hours (>1 hour)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Labor Pain']}, 'referencesModule': {'references': [{'pmid': '23485992', 'type': 'RESULT', 'citation': 'Pan PH, Tonidandel AM, Aschenbrenner CA, Houle TT, Harris LC, Eisenach JC. Predicting acute pain after cesarean delivery using three simple questions. Anesthesiology. 2013 May;118(5):1170-9. doi: 10.1097/ALN.0b013e31828e156f.'}, {'pmid': '27143966', 'type': 'RESULT', 'citation': 'Carvalho B, Zheng M, Harter S, Sultan P. A Prospective Cohort Study Evaluating the Ability of Anticipated Pain, Perceived Analgesic Needs, and Psychological Traits to Predict Pain and Analgesic Usage following Cesarean Delivery. Anesthesiol Res Pract. 2016;2016:7948412. doi: 10.1155/2016/7948412. Epub 2016 Apr 7.'}, {'pmid': '25029661', 'type': 'RESULT', 'citation': 'Carvalho B, Zheng M, Aiono-Le Tagaloa L. A prospective observational study evaluating the ability of prelabor psychological tests to predict labor pain, epidural analgesic consumption, and maternal satisfaction. Anesth Analg. 2014 Sep;119(3):632-640. doi: 10.1213/ANE.0000000000000357.'}]}, 'descriptionModule': {'briefSummary': 'Labor pain is complex to understand and challenging to define because of the interaction of multiple maternal and fetal factors. Poorly controlled acute post-procedural pain may result in harmful physiological and psychological consequences for both mother and baby. It is therefore important to understand the prelabor factors that may affect the labour pain to facilitate the intrapartum pain management. The goal of this prospective observational study is to verify if expectations regarding pain experience translate to actual pain outcomes for women who are undergoing induction of labor.', 'detailedDescription': 'A prospective observational cohort study. 100 parturients having induction of labor that match inclusion criteria will be asked to participate. After written informed consent, vital signs and patient demographics will be obtained and recorded. A 3 question survey will be given. Patients will be asked to rate, using a 0-10 cm visual analog scale (VAS), their anxiety level ("On a scale of 0-10 cm, with 0 being not anxious at all through 10 being extremely anxious, how anxious are you about your upcoming labor and delivery?"), their anticipated pain ("On a scale of 0-10, with 0 being no pain at all and 10 being pain as bad as you can imagine, how much pain do you anticipate experiencing during your upcoming labor and delivery?"), and using a categorical scale, to rate their anticipated epidural analgesic need ("On a scale of 0-5, with 0 being none at all, 1 being much less than average, 2 being less than average, 3 being average, 4 being more than average, and 5 being much more than average, how much epidural pain medication do you anticipate needing during your upcoming labor and delivery?"). Then 24 hours after delivery, patient VAS scores will be recorded, number of boluses, total number of hours of labor, patient comfort level and satisfaction'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy full term pregnant patients with singleton pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. The patient is 18 years or older\n2. ASA class II or III according to the 2014 American Society of Anesthesiologists' physical status classification\n3. The patient is having induction of labor\n4. The patient is having a singleton pregnancy\n5. the fetus's gestational age is more than 37 weeks\n6. the patient is considering having epidural analgesia.\n\nExclusion criteria:\n\n1. The patient has refused to participate\n2. There is a language barrier between the patient and the investigator\n3. The patient received narcotics within the last two hours\n4. the patient has chronic pain issues\n5. There is significant concern about maternal or fetal welfare\n6. The patient has a history of opioid tolerance\n7. The patient has major psychiatric problem,\n8. There is contraindication to epidural labor analgesia\n9. Patient has allergy to local anesthetics."}, 'identificationModule': {'nctId': 'NCT02824302', 'briefTitle': '3 Simple Questions to Predict Labor Pain and Epidural Analgesia Use in Parturients', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'A Prospective Observational Study to Evaluate Efficacy of Simple Questions to Predict Labor Pain and Epidural Analgesia Use in Parturients', 'orgStudyIdInfo': {'id': '107817'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'Patients coming for induction of labor will be handed a survey regarding their expectation of their coming labor pain. And then will be followed up after 24 hours of their delivery.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Science Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}