Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-11 @ 2:13 AM
Study NCT ID:
NCT03287258
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2017-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perineal Preparation for Pregnant Ladies.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-31', 'studyFirstSubmitDate': '2017-07-22', 'studyFirstSubmitQcDate': '2017-09-18', 'lastUpdatePostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'perineal tears Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery', 'timeFrame': 'At 15 minutes from delivery', 'description': 'Proportion of participants who have perineal tears'}], 'secondaryOutcomes': [{'measure': 'episiotomy need Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator', 'timeFrame': 'At 15 minutes from delivery', 'description': 'Proportion of participants who need episiotomy at time of delivery'}, {'measure': 'Duration of the second stage of labour', 'timeFrame': '2 hours', 'description': 'Duration of the second stage of labour will be assessed by an investigator'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['perineal massage', 'health education', 'perineal tear', 'episiotomy', 'pelvic floor muscle exercise'], 'conditions': ['Delivery; Trauma', 'Pelvic Floor; Perineal Rupture, Obstetric', 'Pelvic Floor Muscle Weakness']}, 'descriptionModule': {'briefSummary': 'Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual education program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.', 'detailedDescription': 'Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual educational pelvic floor dysfunction prevention program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women ≥ 35 years old\n* Primigravida or multi gravida\n\nExclusion Criteria:\n\n* History of chronic constipation\n* History of chronic cough\n* Current or past urinary or anal incontinence\n* History of genital prolapse before pregnancy\n* History of neuromuscular disorders or connective tissue disorders\n* History of medical disorders\n* History of preterm or precipitate labour\n* History of premature preterm rupture of membranes.\n* Genital infections'}, 'identificationModule': {'nctId': 'NCT03287258', 'briefTitle': 'Perineal Preparation for Pregnant Ladies.', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Digital Perineal Massage and Pelvic Floor Muscle Exercise as an Antenatal Program for Prevention of Perineal Trauma in Elderly Women, a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'perineal preparation study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'three program', 'description': '200 patients are subjected to educational Pelvic floor dysfunction prevention program with perineal massage and Pelvic floor muscle exercise.', 'interventionNames': ['Other: 3 program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'one program', 'description': '200 patients are subjected to educational Pelvic floor dysfunction prevention program', 'interventionNames': ['Other: one program']}], 'interventions': [{'name': '3 program', 'type': 'OTHER', 'description': 'The participants will receive 3 programs.The educational pelvic floor dysfunction prevention program, pelvic floor muscle exercise program and perineal massage program will be educated by an investigator during the participant visit 4 weeks before her due date', 'armGroupLabels': ['three program']}, {'name': 'one program', 'type': 'OTHER', 'description': 'The participants will receive one program. That is the educational pelvic floor dysfunction prevention program.The instructions of the program will be given by an investigator once during the participant visit 4 weeks before her due date.', 'armGroupLabels': ['one program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11956', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'KasralainiH', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Amira Dieb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KasrAlainiH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital', 'investigatorFullName': 'Amira S Dieb', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}