Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-27 @ 10:33 PM
Study NCT ID:
NCT00127361
Status:
COMPLETED
Last Update Posted:
2005-08-23
First Post:
2005-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Having a Female Friend as Labor Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-04', 'completionDateStruct': {'date': '2003-02'}, 'lastUpdateSubmitDate': '2005-08-22', 'studyFirstSubmitDate': '2005-08-04', 'studyFirstSubmitQcDate': '2005-08-04', 'lastUpdatePostDateStruct': {'date': '2005-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of labor'}, {'measure': 'type of delivery'}, {'measure': 'type and timing of analgesia/anesthesia'}], 'secondaryOutcomes': [{'measure': 'Birthweight'}, {'measure': 'neonatal Apgar score at 1 and 5 minutes after birth'}]}, 'conditionsModule': {'keywords': ['doula', 'caregivers', 'labor support', 'being with woman', 'continuous labor support', 'maternal outcomes', 'Parturition'], 'conditions': ['Pregnancy', 'Delivery, Obstetric']}, 'descriptionModule': {'briefSummary': "The purpose of this study was to compare labor outcomes in women accompanied by an additional support person (doula group) with outcomes in women who did not have this additional support person (control group).\n\nThe current study was designed with the benefits of continuous labor support in mind as well as the need for a cost-effective, affordable program to provide those services for low-income women. Its purpose was to evaluate the effects of continuous labor support provided by a female companion of the pregnant person's choosing who, with the mother, had participated in an educational program to teach her how to provide continuous labor support.", 'detailedDescription': 'The purpose of this study was to evaluate the influence of a female companion in labor who had been chosen by a nulliparous, underinsured, low-income woman and who had received brief training in supportive labor techniques. The objective was to compare labor outcomes, specifically cesarean section rates, in women accompanied by this additional support person (doula group) with outcomes in women who did not have this additional support person (control group).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nulliparous (never given birth before)\n* Singleton pregnancy\n* Vertex presentation\n* Low risk pregnancy\n* Has a female friend willing to be a doula\n\nExclusion Criteria:\n\n* Placenta previa\n* Abruptio placenta\n* Multiple pregnancy\n* Breech presentation\n* Planned operative delivery'}, 'identificationModule': {'nctId': 'NCT00127361', 'briefTitle': 'Study of Having a Female Friend as Labor Support', 'organization': {'class': 'OTHER', 'fullName': 'Saint Peters University Hospital'}, 'officialTitle': 'Evaluation of Continuous Support in Labor', 'orgStudyIdInfo': {'id': 'DAC-1998'}}, 'armsInterventionsModule': {'interventions': [{'name': 'doula training', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07109', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Saint Peters University Hospital', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Della A Campbell, PhDc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Peters University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Peters University Hospital', 'class': 'OTHER'}}}}