Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-29 @ 3:01 AM
Study NCT ID:
NCT01578369
Status:
COMPLETED
Last Update Posted:
2012-04-16
First Post:
2012-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pelvic Floor Muscle Training Included in General Fitness Classes During Pregnacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-13', 'studyFirstSubmitDate': '2012-04-11', 'studyFirstSubmitQcDate': '2012-04-13', 'lastUpdatePostDateStruct': {'date': '2012-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire', 'timeFrame': 'Week 10-14 gestation (baseline), week 36-39 (after intervention)'}], 'secondaryOutcomes': [{'measure': "Change from baseline in King's Health Questionnaire", 'timeFrame': 'week 10-14 of gestation (baseline), week 36-39 (after intervention)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urinary incontinence', 'Pregnancy', 'Pelvic floor muscle training'], 'conditions': ['Pregnancy', 'Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '32378735', 'type': 'DERIVED', 'citation': 'Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.'}, {'pmid': '23389863', 'type': 'DERIVED', 'citation': 'Pelaez M, Gonzalez-Cerron S, Montejo R, Barakat R. Pelvic floor muscle training included in a pregnancy exercise program is effective in primary prevention of urinary incontinence: a randomized controlled trial. Neurourol Urodyn. 2014 Jan;33(1):67-71. doi: 10.1002/nau.22381. Epub 2013 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the effect of pelvic floor muscle training taught in a general exercise class during pregnancy to prevent urinary incontinence in nulliparous continent pregnant women.', 'detailedDescription': 'Pregnancy and childbirth are known risk factors for development of female urinary incontinence (UI). Studies have found that Pelvic Floor Mucle Trainig (PFMT) is effective in preventing and reducing UI during pregnancy and after childbirth. However, in a recent study, no effect was found when PFMT were taught in a general fitness class without former palpation of the pelvic floor muscles (Bo y Haakstad, 2011).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nulliparous with singleton baby\n* Not suffering from urinary incontinence\n* Giving birth at Hospital Universitario de Fuenlabrada\n* Able to comunicate in Spanish\n* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines\n\nExclusion Criteria:\n\n* Multiparity\n* At risk of Premature birth\n* Following another exercise program'}, 'identificationModule': {'nctId': 'NCT01578369', 'briefTitle': 'Effect of Pelvic Floor Muscle Training Included in General Fitness Classes During Pregnacy', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Politecnica de Madrid'}, 'officialTitle': 'Pelvic Floor Muscle Training Included in General Fitness Classes is Effective in Primary Prevention of Urinary Incontince in Pregnancy. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '240/09B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'Supervised exercise classes which included pelvic floor muscle training. 3 sessions per week. 55-60 min per session, with 10 minutes of pelvic floor muscle training. At least during 22 weeks.', 'interventionNames': ['Other: Exercise classes with pelvic floor muscle training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual care'}], 'interventions': [{'name': 'Exercise classes with pelvic floor muscle training', 'type': 'OTHER', 'description': 'Supervised exercise classes which included pelvic floor muscle training. 3 sessions per week. 55-60 min per session, with 10 minutes of pelvic floor muscle training. At least during 22 weeks.', 'armGroupLabels': ['Exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Politécnica de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Rubén Barakat, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad Politecnica de Madrid'}, {'name': 'Mireia Peláez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Politecnica de Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Politecnica de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Mireia Pelaez Puente', 'investigatorAffiliation': 'Universidad Politecnica de Madrid'}}}}