Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-01-01 @ 9:37 PM
Study NCT ID:
NCT07157059
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2025-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Labor and Delivery Doula Program to Reduce Perinatal Morbidity and Mortality in Kansas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-05', 'releaseDate': '2025-11-24'}, {'releaseDate': '2025-12-19'}], 'estimatedResultsFirstSubmitDate': '2025-11-24'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-18', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceptions of provider communication', 'timeFrame': '14-28 weeks GA through 6-weeks postpartum', 'description': 'Assess perceptions of provider communication using Likert-scale surveys (including some yes/no questions and comments).'}, {'measure': 'Perceptions of maternal care', 'timeFrame': '14-28 weeks GA through 6-weeks postpartum', 'description': 'Assess perceptions of maternal care using Likert-scale surveys (including some yes/no questions and comments).'}], 'secondaryOutcomes': [{'measure': 'Perinatal outcome - gestational age (GA) at delivery', 'timeFrame': '14-28 weeks GA through delivery', 'description': 'Assess gestational age (GA) at delivery by collecting data from their patient surveys and chart.'}, {'measure': 'Perinatal outcome - preterm <37 weeks births', 'timeFrame': '14-28 weeks GA through delivery', 'description': 'Assess preterm \\<37 weeks births by collecting data from their patient surveys and chart.'}, {'measure': 'Perinatal outcome - cesarean sections', 'timeFrame': '14-28 weeks GA through delivery', 'description': 'Assess cesarean sections by collecting data from their patient surveys and chart.'}, {'measure': 'Perinatal outcome - gestational hypertension/Preeclampsia', 'timeFrame': '14-28 weeks GA through delivery', 'description': 'Assess gestational hypertension/Preeclampsia by collecting data from their patient surveys and chart.'}, {'measure': 'Neonatal morbidity', 'timeFrame': 'Birth through 6-weeks postpartum', 'description': 'Assess neonatal morbidity by collecting neonatal APAGAR scores and neonatal ICU admissions'}, {'measure': 'Antepartum depression', 'timeFrame': '14-28 weeks GA through delivery', 'description': 'Assess depression using Edinburgh depression screening tool'}, {'measure': 'Postpartum depression', 'timeFrame': 'Birth (delivery) through 6-weeks postpartum', 'description': 'Assess depression using Edinburgh depression screening tool'}, {'measure': 'Maternal pain management', 'timeFrame': 'Birth through 6-weeks postpartum', 'description': 'Assess pain management via postpartum pain perception scores and total morphine milliequivalent used.'}, {'measure': 'Lactation Status', 'timeFrame': 'Birth through 6-weeks postpartum', 'description': 'Assess lactation status was asked and recorded for patients during their labor and delivery admission and postpartum visits'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related', 'Doula Care', 'Black Maternal and Infant Health', 'Prenatal Care']}, 'descriptionModule': {'briefSummary': 'The study was done to learn how doula-enhanced care provided to Black birthing people improved perceived communication and quality care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Black birthing people\n* Received care and plan to delivery at the University of Kansas Medical Center\n* Scored positive to social determinants of health screener\n* Gestational age between 14-27.6 weeks at enrollment\n\nExclusion Criteria:\n\n* Pregnancy not viable or pregnancy not intrauterine on ultrasound\n* Patients who are not willing to be randomized into not receiving doula enhanced\n* Patients who do not plan to delivery at the University of Kansas Health System\n* Non-Black birthing people.\n* Planned cesarean section\n* Patients with a known major fetal anomaly\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT07157059', 'acronym': 'Doula', 'briefTitle': 'Labor and Delivery Doula Program to Reduce Perinatal Morbidity and Mortality in Kansas', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Labor and Delivery Doula Program to Reduce Perinatal Morbidity and Mortality in Kansas', 'orgStudyIdInfo': {'id': 'STUDY00161314'}, 'secondaryIdInfos': [{'id': 'FP00000002', 'type': 'OTHER_GRANT', 'domain': 'BioNexus KC'}, {'id': 'IRB STUDY00149318', 'type': 'OTHER', 'domain': 'The University of Kansas Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Doula-Enhanced Care Group', 'description': 'This group received doula-enhanced care along with routine pregnancy care.', 'interventionNames': ['Behavioral: Doula Care']}, {'type': 'NO_INTERVENTION', 'label': 'Routine Pregnancy Care Group', 'description': 'This group received routine pregnancy care.'}], 'interventions': [{'name': 'Doula Care', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.', 'armGroupLabels': ['Doula-Enhanced Care Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'The University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Angela Martin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioNexus KC', 'class': 'UNKNOWN'}, {'name': 'Blue KC (Blue Cross Blue Shield)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-24', 'type': 'RELEASE'}, {'date': '2025-12-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Kansas Medical Center'}}}}