Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-30 @ 3:39 AM
Study NCT ID:
NCT03839004
Status:
UNKNOWN
Last Update Posted:
2019-02-12
First Post:
2019-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MYND&CO: Studio Pilota Dell'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza
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': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-11', 'studyFirstSubmitDate': '2019-01-10', 'studyFirstSubmitQcDate': '2019-02-11', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Evolution in women's mental health from t0( first trimester) to after birth (40 days after delivery)", 'timeFrame': 'from third month of pregnancy to 1 month after delivery', 'description': 'evaluated by the means of psychological questionaire SF12'}, {'measure': "Woman's physical health during pregnancy", 'timeFrame': 'from first trimester of pregnancy to day of delivery', 'description': 'weight gain in pregnancy'}, {'measure': 'Diagnosis of pregnancy-related diabetes', 'timeFrame': 'from 24 weeks of pregnancy to the day of delivery', 'description': 'positive blood glucose curve or fasting glucose \\>92 on 2 different measurements'}, {'measure': 'Diagnosis of pregnancy-related hypertension', 'timeFrame': 'from the 20th week of gestation to 40 days after delivery', 'description': 'diagnosis of hypertension from the 20th week of gestation to 40 days after delivery'}, {'measure': "Woman's osteo-muscular health during pregnancy", 'timeFrame': 'from the 20th week of gestation to 40 days after delivery', 'description': 'diagnosis of low back pain and sciatic nerve pain during pregnancy'}, {'measure': 'Quality of delivery', 'timeFrame': 'birth', 'description': 'number of operative deliveries/ cesarean sections'}, {'measure': "Newborn's health", 'timeFrame': 'birth', 'description': 'apgar'}, {'measure': "Newborn's pH", 'timeFrame': 'birth', 'description': 'pH at birth'}, {'measure': "Newborn's weight", 'timeFrame': 'birth', 'description': 'weight at birth'}, {'measure': "Newborn's blood gas", 'timeFrame': 'birth', 'description': 'blood gas at birth'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy', 'Mental Health Wellness 1']}, 'referencesModule': {'references': [{'pmid': '34328141', 'type': 'DERIVED', 'citation': 'Giovannini N, Cetera GE, Ercolino C, Miozzo MR, Parazzini F, Ferrazzi EM, Manzotti A, Colaceci S. MYNd&CO (Mindfulness, Yoga, Nutrition, development & Coaching, and Osteopathy) randomized controlled trial for a positive psychophysical experience in pregnancy and after birth: a study protocol. Acta Biomed. 2021 Jul 29;92(S2):e2021032. doi: 10.23750/abm.v92iS2.11259.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate an integral approach to the maternal-fetal diad.\n\nA randomized non farmacological monocentric trial.\n\n400 women with single spontaneous pregnancies are randomized.\n\n200 recieve standardized traditional obstetrical care\n\n200 recieve nutritional advice, osteopathic treatment, yoga classes, mindfulness classes and coaching as well as regular obstetrical care.\n\nWe evaluate the psychological status at recruitment, at the end of pregnancy and 40 days after birth.', 'detailedDescription': 'The first international scientific research project focusing on a holistic approach to pregnancy is starting now at the Clinica Mangiagalli in Milan.\n\nThis innovative model aims to the gold standard of a "positive pregnancy", which supports both the somatic and psychological component of the mother-newborn unit, and thus organically and proactively prevents the main issues arising during pregnancy and delivery due to unhealthy lifestyles.\n\nA team of experts will take comprehensive care of the mother, first by means of an accurate evaluation of her nutritional profile, and then of her biomechanic (osteo-skeletal) state.\n\nThen, the experts will lead an "academic" path, which will initiate a development of her biochemistry (through nutrition), respiration (through yoga), physical wellbeing (through osteopathy and yoga); and strengthen her sense of self, removing her self-doubt (through mindfulness and yoga).\n\nThe women will be supported up until childbirth, so as to attempt to prevent the main complications of pregnancy and of delivery.\n\nThis model does not aim to substitute the allopathic one which is currently in place (ultrasounds, ob-gyn appointments, tests, etc.), but to enhance its nature in a more effectively THERAPEUTIC manner, increasing the mother-newborn unit\'s potential of health.\n\nIn summary:\n\n* Weekly mindfulness meet-ups\n* Weekly yoga meet-ups\n* Nutritional screening and further check-ups, if needed\n* Osteopathic screening\n* Five motivational meetings with a coach\n* Four obstetrical appointments\n* Obstetrical screening and check-ups up until childbirth\n\nThe team in charge of the project is made up of gynaecologists, midwives, psychologists, osteopaths, nutritionists and yoga teachers, who all collaborate on a regular basis with the Clinica Mangiagalli.\n\nThe project is offered to women free of charge.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton pregnancies\n* spontaneous pregnancies\n* no maternal medical conditions\n* no language barrier\n\nExclusion Criteria:\n\n* maternal or fetal medical conditions\n* age \\<18 or \\<45\n* ivf\n* language barrier\n* multiple pregnancies'}, 'identificationModule': {'nctId': 'NCT03839004', 'acronym': 'MYND&CO', 'briefTitle': "MYND&CO: Studio Pilota Dell'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza", 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': '"MYND&CO: Studio Pilota Sull\'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza Secondo Una modalità Multidisciplinare e Personalizzata"', 'orgStudyIdInfo': {'id': 'MYND&CO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': '200 woman with single spontaneous pregnancies who recieve, as well as traditional obstetrical care, yoga classes, myndfulness classes, coaching, nutrition counselling and osteopathic treatment', 'interventionNames': ['Behavioral: Integrated approach to pregnancy']}, {'type': 'NO_INTERVENTION', 'label': 'Controls', 'description': '200 woman with single spontaneous pregnancies recieving traditional obstetrical care'}], 'interventions': [{'name': 'Integrated approach to pregnancy', 'type': 'BEHAVIORAL', 'description': 'Yoga classes, mindfulness classes, coaching, nutrition counselling and osteopathy', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Clinica Mangiagalli', 'role': 'CONTACT', 'email': 'comunicazione@policlinico.mi.it', 'phone': '02.5503'}], 'facility': "Fondazione IRCCS Ca' Granda", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': "Niccolo' Giovannini, Dr.", 'role': 'CONTACT', 'email': 'niccolo.giovannini@policlinico.mi.it', 'phone': '00393387026884'}, {'name': 'Giulia Emily Cetera, Dr.', 'role': 'CONTACT', 'email': 'giuliaemily.cetera@gmail.com', 'phone': '00393356583395'}], 'overallOfficials': [{'name': 'Niccolò Giovannini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Clinica Mangiagalli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual participant data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}