Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT03715218
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2018-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Mothers Touch Program to Improve Maternal Health After Birth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2018-10-19', 'studyFirstSubmitQcDate': '2018-10-19', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Post-natal depression', 'timeFrame': '6 weeks following child birth', 'description': 'Changes were assessed using Edinburgh Postnatal Depression scale'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of Life', 'timeFrame': '6 weeks following child birth', 'description': 'Quality of life was measured using Short Form-36'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Partum Depression', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '34286512', 'type': 'DERIVED', 'citation': 'Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.'}]}, 'descriptionModule': {'briefSummary': "After the child birth most women experience major health issues such as depression, severe fatigue, back pain, perineal pain, mastitis, urinary or faecal incontinence, sexual problems and relationship problems with partners. That all lead to poorer emotional and mental health and factors contributing isolation, exhaustion and physical health problems.\n\n'Sava Mahina (6-week period) is a traditional practice for postpartum women in India, which include special diet, lifestyle and supportive care. The current multicenter randomized controlled trial (RCT) aims to evaluate outcomes of Indian postpartum care on women."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primigravida\n* Healthy pregnancy\n* Consent to participate\n\nExclusion Criteria:\n\n* Mental Health diagnosis\n* Severe depression or psychosis\n* Substance abuse'}, 'identificationModule': {'nctId': 'NCT03715218', 'briefTitle': 'Impact of Mothers Touch Program to Improve Maternal Health After Birth', 'organization': {'class': 'OTHER', 'fullName': 'NMP Medical Research Institute'}, 'officialTitle': 'Indian Postpartum Care: A-randomised Trial to Improve Maternal Health Six Weeks After Birth', 'orgStudyIdInfo': {'id': 'NMP 0146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mother Touch Program', 'description': 'Post natal care provided by trained carer after the birth. 6 weeks of care included massage, special diet, physical and mental relaxations.', 'interventionNames': ['Other: Mothers Touch Program']}, {'type': 'OTHER', 'label': 'Usual care Program', 'description': 'Usual care and supervision was provided as usual.', 'interventionNames': ['Other: Usual Care Program']}], 'interventions': [{'name': 'Mothers Touch Program', 'type': 'OTHER', 'description': 'Mothers Touch Program with bed rest, Relaxation program to reduce stress, massage for mother and infant, gently physical exercise and special dietary program each week.', 'armGroupLabels': ['Mother Touch Program']}, {'name': 'Usual Care Program', 'type': 'OTHER', 'description': 'Usual care group had advice, support and educational program delivered by midwife, or physicians.', 'armGroupLabels': ['Usual care Program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'NMP Medical Reserach Institute', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}], 'overallOfficials': [{'name': 'Rekha Chaudhari', 'role': 'STUDY_CHAIR', 'affiliation': 'Mothers Touch Foundation, India'}, {'name': 'Neha Sharma', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Warwick Research Services'}, {'name': 'Sangram Birje', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mothers Touch Foundation, India'}, {'name': 'Aparna Chaudhari', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mothers Touch Foundation, India'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NMP Medical Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Warwick Research Services', 'class': 'OTHER'}, {'name': 'Mothers Touch Foundation, India', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}