Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-29 @ 4:26 PM
Study NCT ID:
NCT06395168
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2024-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mayo Clinic Health System Northwest Wisconsin Integrated Maternal Postpartum Appointment Combination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 246}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2024-04-29', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of breastfeeding rates with a combined lactation/newborn visit versus separate visits.', 'timeFrame': 'Duration of the study (expected 1 year)', 'description': 'Looking for the difference of breastfeeding continuation between the intervention and control group. Hypothesis is higher breastfeeding rates in the combined lactation/newborn visit.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Feeding']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore whether combining the first post-hospital newborn provider visit and lactation consultation into a single appointment can enhance rates of successful breastfeeding initiation and continuation at predefined intervals (e.g., one week, one month, two months, three months, four months, six months, and 12 months postpartum).', 'detailedDescription': 'This interventional, comparative effectiveness study investigates the impact of integrating the first newborn outpatient provider and lactation consultant visits, potentially reducing appointments for new mothers while ensuring early lactation support. The outcomes, including breastfeeding continuation rates and maternal satisfaction, will be measured against the conventional separate visit model. The ultimate goal is to prolong breastfeeding duration, enhance care quality, improve efficiency, and enrich patient experience.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers aged greater than or equal to 18 years.\n* Mothers who are able to provide informed consent for participation in this study.\n* Mothers registered as patients at Mayo Clinic Health System Northwest Wisconsin.\n* Mothers who have given birth within the past four days prior to enrollment into this study.\n* Mothers who intend to breastfeed their newborns.\n* Mothers who are willing and able to participate in this study.\n* Mothers who are able to communicate in English.\n* Mothers with the ability to connect to the internet and complete electronic data collection.\n\nExclusion Criteria:\n\n* Mothers who are unable or unwilling to provide informed consent for participation in this study.\n* Mothers less than 18 years of age.\n* Mothers unable to complete study procedures or follow-up visits.\n* Mothers with medical complications that could interfere with breastfeeding (e.g., breast reduction).\n* Mothers who have no intention to breastfeed their newborns.\n* Mothers who are unwilling to follow up with lactation.\n* Infants who have already had their first postpartum outpatient provider visit.\n* Pre-term infants (less than 37 weeks).\n* Special care admission greater than two days.\n* Length of stay or anticipated LOS greater than four days.\n* Transfer to an outside facility.\n* Inability to communicate in English.\n* When slots are no longer available.'}, 'identificationModule': {'nctId': 'NCT06395168', 'acronym': 'IMPAC', 'briefTitle': 'Mayo Clinic Health System Northwest Wisconsin Integrated Maternal Postpartum Appointment Combination', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'IMPAC: Integrated Maternal Postpartum Appointment Combination in Mayo Clinic Health System Northwest Wisconsin', 'orgStudyIdInfo': {'id': '23-012862'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Combined Lactation and Newborn visit', 'description': 'This arm is the intervention where the newborn visit with the pediatric provider is within a lactation consultant visit for a breastfeeding newborn and mother.', 'interventionNames': ['Other: Combined Newborn and Lactation Visit']}, {'type': 'NO_INTERVENTION', 'label': 'Separate Lactation and Newborn visit', 'description': 'This is current state of care in which a newborn visit is separate and apart from a Lactation Consultation.'}], 'interventions': [{'name': 'Combined Newborn and Lactation Visit', 'type': 'OTHER', 'description': 'See Arm/Group Description', 'armGroupLabels': ['Combined Lactation and Newborn visit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54703', 'city': 'Eau Claire', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Thompson, CNP, DNP, APNP', 'role': 'CONTACT', 'email': 'thompson.melissa3@mayo.edu', 'phone': '715-838-5025'}], 'facility': 'Mayo Clinic Health System-Eau Claire Clinic', 'geoPoint': {'lat': 44.81135, 'lon': -91.49849}}], 'centralContacts': [{'name': 'Linh Tran', 'role': 'CONTACT', 'phone': '715-838-5871'}], 'overallOfficials': [{'name': 'Melissa Thompson, CNP, DNP, APNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Melissa A. Thompson', 'investigatorAffiliation': 'Mayo Clinic'}}}}