Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-01 @ 2:12 PM
Study NCT ID:
NCT00755092
Status:
COMPLETED
Last Update Posted:
2009-02-11
First Post:
2008-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Doula in Nulliparas and Multiparas
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': 'D059037', 'term': 'Doulas'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-10', 'studyFirstSubmitDate': '2008-09-17', 'studyFirstSubmitQcDate': '2008-09-17', 'lastUpdatePostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS pain intensity', 'timeFrame': 'From the beginning of regular contraction of uterus to the end of delivery'}], 'secondaryOutcomes': [{'measure': 'Ramsey sedative scale', 'timeFrame': 'From the beginning of regular contraction of uterus to the end of delivery'}, {'measure': 'Blood levels of corticosteroid', 'timeFrame': '10 min prior to Doula, 5, 10, 15, 30, 60, 120 min after Doula support and at the end of the delivery'}, {'measure': 'Vital signs', 'timeFrame': 'From the beginning of regular contraction of uterus to the end of delivery'}, {'measure': 'Adverse events', 'timeFrame': 'From the beginning of regular contraction of uterus to the end of delivery'}, {'measure': 'Infant outcomes', 'timeFrame': 'The time of delivery to 1 h after delivery'}, {'measure': 'Cesarean rate', 'timeFrame': 'During the whole period of laboring'}, {'measure': 'Overall feeling of satisfaction of analgesia', 'timeFrame': 'From the beginning of regular contraction of uterus to the end of the labor'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Doula', 'Psychological care', 'Labor analgesia'], 'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'Psychological care during labor is considered as an important supplemental procedure for alleviating delivering stress and pain. Although Doula has been recommending that should be given for parturients, its precise effect on nulliparous and multiparous women is still unknown. The investigators hypothesized that multiparas had experienced the process of labor, but the nulliparas were not, so Doula support would produce different effect on these two population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy term parturients\n* Chinese\n* 19-45 years\n\nExclusion Criteria:\n\n* Organic dysfunction\n* Participants younger than 19 years or older than 45 years\n* Those who were not willing to or could not finish the whole study at any time\n* Pregnancy-induced hypertension and diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT00755092', 'acronym': 'DINAM', 'briefTitle': 'Effect of Doula in Nulliparas and Multiparas', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Analgesic Efficacy of Doula in Nulliparous and Multiparous Women', 'orgStudyIdInfo': {'id': 'NMU-FY2008-416'}, 'secondaryIdInfos': [{'id': 'NJFY-MZ08092'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Doula for Nulliparous women', 'interventionNames': ['Behavioral: Doula']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Doula for Multiparous women', 'interventionNames': ['Behavioral: Doula']}], 'interventions': [{'name': 'Doula', 'type': 'BEHAVIORAL', 'description': 'Doula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery', 'armGroupLabels': ['1']}, {'name': 'Doula', 'type': 'BEHAVIORAL', 'description': 'Doula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210004', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'XiaoFeng Shen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'XiaoFeng Shen', 'oldOrganization': 'Nanjing Medical University'}}}}