Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-09 @ 2:16 AM
Study NCT ID:
NCT03875794
Status:
TERMINATED
Last Update Posted:
2022-04-29
First Post:
2019-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'There is no one to transfer to study to and no one interested in this research study. I am taking 8 months off from being a physician so the study needs to be closed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-25', 'studyFirstSubmitDate': '2019-03-13', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lactation Volume', 'timeFrame': 'Baseline through 4 weeks', 'description': 'Measuring lactation volume after osteopathic manipulation in ounces.'}], 'secondaryOutcomes': [{'measure': 'Change in formula supplementation', 'timeFrame': 'Baseline to 4 weeks', 'description': 'Change in lactation production in order to change the number of ounces needed for formula supplementation.'}, {'measure': 'Change in reported self-worth', 'timeFrame': 'Baseline to 4 weeks', 'description': 'Change in subject reported self-worth as assessed on an Investigator developed questionnaire (based off the Patient-Reported Outcomes Measurement Information System \\[PROMIS\\] questionnaire on a 5 point Likert scale).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lactation; Insufficient, Partial', 'Lactating Female'], 'conditions': ['Osteopathic Manipulation']}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate whether using osteopathic manipulation can increase the milk supply in lactating women.', 'detailedDescription': 'The short and long-term benefits of breastfeeding to both the mother and infant are well established. Benefits for the child range from protection against common childhood infections, decreased rates of type-2 diabetes and systolic hypertension, lower rate of sudden infant death syndrome, increased performance on intelligence tests, and possible reduction in obesity. Maternal benefits include a reduction in the risk of breast cancer, diabetes, hyperlipidemia, hypertension, myocardial infarction, obesity, and ovarian cancer. Given this evidence the World Health Organization (WHO) and the American Academy of Pediatrics recommend, exclusive breastfeeding of infants for the first six months. WHO goes on to recommend breastfeeding to 2 years and beyond if mutually agreeable to both the mother and child. Despite these benefits and recommendations, according to the Centers for Disease Control and Prevention (CDC) in the United States 81% of infants were started breastfeeding and only 51% continued at 6 months. Perceived or actual low milk supply is one of the most common reasons for discontinuing breastfeeding.\n\nThis protocol is designed to investigate scientifically our current osteopathic standard of care. There is no available research data to date specifically on using osteopathic manipulation as an intervention to increase milk supply in lactating women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Lactating females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 - 40\n2. Between 2 and 28 weeks postpartum from a live infant birth weighing at least 2500g\n3. Desire to exclusively breastfeed\n4. Able to provide informed consent\n5. Available for the duration of the study\n6. 1 hour milk volume of less than 1oz (or 2oz for twins)\n7. All current nurslings are the same age\n\nExclusion Criteria:\n\n1. Current use of domperidone\n2. Current use of metoclopramide\n3. Current use of silymarin\n4. History of breast surgery\n5. Current malignancy\n6. Current pulmonary embolism or deep vein thrombosis\n7. Current medical condition resulting in increased intra-cranial pressure\n8. History of insufficient glandular tissue (IGT)'}, 'identificationModule': {'nctId': 'NCT03875794', 'briefTitle': 'OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)', 'orgStudyIdInfo': {'id': '1174025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osteopathic Manipulation', 'description': 'This research will be carried out as a prospective, non-randomized pilot study in women aged 18-40 who are 2 weeks to 28 weeks postpartum.\n\nThe intervention investigated in this study is osteopathic manipulation.', 'interventionNames': ['Other: Osteopathic Manipulation']}], 'interventions': [{'name': 'Osteopathic Manipulation', 'type': 'OTHER', 'description': 'Using osteopathic manipulation as an intervention to increase milk supply in lactating women.', 'armGroupLabels': ['Osteopathic Manipulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32822', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth East Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': "Arlene O'Donnell, DO", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}