Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT00664118
Status:
COMPLETED
Last Update Posted:
2009-05-27
First Post:
2008-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women
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': 'D000698', 'term': 'Analgesia'}, {'id': 'D059037', 'term': 'Doulas'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-26', 'studyFirstSubmitDate': '2008-04-18', 'studyFirstSubmitQcDate': '2008-04-21', 'lastUpdatePostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of cesarean delivery', 'timeFrame': 'Analgesia initiation (0 h) to completion of vaginal delivery (4-7 h)'}], 'secondaryOutcomes': [{'measure': 'Rate of instrumental delivery', 'timeFrame': 'Analgesia initiation (0 h) to successful vaginal delivery (4-7 h)'}, {'measure': 'Indications of cesarean delivery', 'timeFrame': 'Analgesia initiation (0 h) to cesarean section (4-7 h)'}, {'measure': 'Maternal Visual Analog Scale (VAS) rating of pain', 'timeFrame': '15 min prior to analgesia, 0-3 h of the latent phrase, 2-3 h of the active phrase, 1-2 h of the second stage of labor, 15 min posterior to delivery'}, {'measure': 'Incidence of side effects', 'timeFrame': 'The whole period of the analgesia to successful vaginal delivery'}, {'measure': 'Low back pain at 3 months after vaginal delivery', 'timeFrame': 'Three months after vaginal delivery'}, {'measure': 'Maternal oral temperature', 'timeFrame': 'The whole period of the analgesia to successful vaginal delivery'}, {'measure': 'Use of oxytocin after analgesia', 'timeFrame': 'During the whole period of the analgesia'}, {'measure': 'Maximal oxytocin dose', 'timeFrame': '30 min after vaginal delivery'}, {'measure': 'Duration of analgesia', 'timeFrame': 'Initiation of analgesia (0h) to the disappearance of sensory block (4-8h)'}, {'measure': 'Breastfeeding success at 6 weeks after vaginal delivery', 'timeFrame': 'Six weeks after successful delivery'}, {'measure': 'Maternal satisfaction with analgesia', 'timeFrame': '30 min after the vaginal delivery'}, {'measure': 'Neonatal one-minute Apgar scale', 'timeFrame': 'One minute after baby was born'}, {'measure': 'Neonatal five-minute Apgar scale', 'timeFrame': 'Five minutes after baby was born'}, {'measure': 'Umbilical-cord gases analysis', 'timeFrame': 'Immediately after baby was born'}, {'measure': 'Neonatal sepsis evaluation', 'timeFrame': '5 min after the baby was born'}, {'measure': 'Neonatal antibiotic treatment', 'timeFrame': '5 min after the baby was born'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Doula', 'Patient-controlled epidural analgesia', 'Neuraxial analgesia', 'Labor analgesia'], 'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'Accumulating evidence indicated that neuraxial analgesia in the latent phase of the first stage of labor would be an effective and safe health care procedure for nulliparas. Doulas, women with labor experience trained for parturients, is a new way to alleviate the psychological stress from the laboring pain. Previous data in our study showed that doula accompany is a good method in shortening the progress of labor used in the active phrase of the first stage of labor, and decreasing the rate of cesarean delivery. Investigators hypothesized that doula combined neuraxial (epidural) analgesia in the latent phrase would be a superior means for effective pain relief, decreased rate of cesarean section, and shortened duration of labor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nulliparous women\n* \\> 18 years and \\< 45 years\n* Spontaneous labor\n* Analgesia request\n\nExclusion Criteria:\n\n* Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records\n* Participants younger than 18 years or older than 45 years\n* Those who were not willing to or could not finish the whole study at any time\n* Using or used in the past 14 days of the monoamine oxidase inhibitors;\n* Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics\n* Subjects with a nonvertex presentation or scheduled induction of labor\n* Cervical dilation was 4.0 cm or greater before performing epidural puncture and catheterization'}, 'identificationModule': {'nctId': 'NCT00664118', 'acronym': 'DCLEAP', 'briefTitle': 'Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'In Combination of Doula and Epidural Analgesia in the Latent Phrase of Labor in Primiparous Women', 'orgStudyIdInfo': {'id': 'NMCHCH-0121-236'}, 'secondaryIdInfos': [{'id': 'NMUC-08022'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Doula combined epidural analgesia in the latent phase of first stage of labor', 'interventionNames': ['Procedure: Doula combined analgesia']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': 'Epidural analgesia in the latent phase of the first stage of labor without doula accompany', 'interventionNames': ['Procedure: Analgesia without doula']}], 'interventions': [{'name': 'Doula combined analgesia', 'type': 'PROCEDURE', 'description': 'Doula combined epidural analgesia in the latent phase of first stage of labor in primiparas', 'armGroupLabels': ['1']}, {'name': 'Analgesia without doula', 'type': 'PROCEDURE', 'description': 'Epidural analgesia in the latent phase of first stage of labor without doula accompany in primiparas', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210004', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Maternal and Child Health Care Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'XiaoFeng Shen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'HRSA/Maternal and Child Health Bureau', 'class': 'FED'}], 'responsibleParty': {'oldNameTitle': 'XiaoFeng Shen', 'oldOrganization': 'Nanjing Medical University'}}}}