Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT00551551
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2007-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prenatal Pelvic Floor Prevention (3PN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D004688', 'term': 'Encopresis'}, {'id': 'D017699', 'term': 'Pelvic Pain'}], '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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059825', 'term': 'Physical Therapists'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-25', 'studyFirstSubmitDate': '2007-10-30', 'studyFirstSubmitQcDate': '2007-10-30', 'lastUpdatePostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary incontinence score assessed with ICIQ-SF questionnaire', 'timeFrame': 'one year post partum'}], 'secondaryOutcomes': [{'measure': 'Urinary incontinence prevalence', 'timeFrame': 'pregnancy end, 2 and 12 months post partum'}, {'measure': 'Other pelvic floor symptoms (anal incontinence, pain, sexual troubles)', 'timeFrame': 'pregnancy end, 2 and 12 months post partum'}, {'measure': 'Genital prolapse assessed by POP-Q', 'timeFrame': '2 months post-partum'}, {'measure': 'Pelvic floor strength', 'timeFrame': '2 months post partum'}, {'measure': 'Quality of life (Euroquol 5D, Contilife)', 'timeFrame': 'at delivery, 2 and 12 months post partum'}, {'measure': 'pad-test', 'timeFrame': '2 months post partum'}, {'measure': 'need to medical care', 'timeFrame': '12 months post partum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pelvic floor', 'Kegel exercises', 'Quality of Life', 'Pelvic Pain'], 'conditions': ['Urinary Incontinence', 'Anal Incontinence', 'Genital Prolapse']}, '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': '26241428', 'type': 'DERIVED', 'citation': 'Fritel X, de Tayrac R, Bader G, Savary D, Gueye A, Deffieux X, Fernandez H, Richet C, Guilhot J, Fauconnier A. Preventing Urinary Incontinence With Supervised Prenatal Pelvic Floor Exercises: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):370-377. doi: 10.1097/AOG.0000000000000972.'}]}, 'descriptionModule': {'briefSummary': 'Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of women with prenatal pelvic floor exercises and a control group.\n\nHypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.', 'detailedDescription': 'Justification:\n\nPelvic floor disorders lead to handicap and medical care consumption. Pregnancy and delivery are the main etiologies. Pelvic floor exercises are proposed for prevention and may reduce immediate postpartum incontinence but we do not know if this preventive effect persists at 1 year.\n\nPrincipal criteria:\n\n* Urinary incontinence score at 12 months post-partum (ICIQ-SF)\n\nSecondary criteria:\n\n* Urinary incontinence prevalence at pregnancy end, 2 and 12 months post-partum\n* Other pelvic floor disorders at pregnancy end, 2 and 12 months post-partum: symptoms questionnaires, QOL questionnaire, Pad-test, POP-Q.\n* Mode of delivery, length of active second phase, perineal tears, Apgar score.\n* Number of postpartum pelvic floor session, number of medical consultations, Kegel exercises.\n\nProgress:\n\n* Inclusion between 20 and 28 weeks, initial assessment, randomization.\n* 8 sessions of pelvic floor exercises with a physiotherapist between 24 and 36 weeks versus written information only.\n* Assessment at pregnancy end, 2 and 12 (+/-1) month post-partum\n\nStudy length:\n\n* For each women 18 months.\n* For each center 30 months.\n\nNumber of subjects:\n\n* To show a 1 point difference on ICIQ-SF score, we need 182 subjects (sd=2,4, a=0,05, β=0,20 bilateral test).\n* Taking in account lost of follow-up (estimated 1/3) we are going to include 280 women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nulliparous\n* aged 18 years or more\n* pregnant between 20 and 28 weeks\n* French language reader\n\nExclusion Criteria:\n\n* No medical insurance\n* multiple or pathologic pregnancy\n* Previous pelvic floor exercises with a physiotherapist less than 6 months before pregnancy'}, 'identificationModule': {'nctId': 'NCT00551551', 'briefTitle': 'Prenatal Pelvic Floor Prevention (3PN)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial', 'orgStudyIdInfo': {'id': '3PN'}, 'secondaryIdInfos': [{'id': 'AFSSAPS-2007-A00641-52'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rééducation', 'description': 'Standardized pelvic floor muscle training program with a physiotherapist in 8 sessions (20-30 minutes each) between 24 and 36 weeks of gestation AND Written instructions about personal (Kegel) pelvic floor exercises', 'interventionNames': ['Other: Pelvic floor muscle training with physiotherapist', 'Other: Written information about kegel exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Written instructions about personal (Kegel) pelvic floor exercises', 'interventionNames': ['Other: Written information about kegel exercises']}], 'interventions': [{'name': 'Pelvic floor muscle training with physiotherapist', 'type': 'OTHER', 'otherNames': ['pelvic floor exercises', 'Pelvic Floor Muscle Training', 'pelvic floor physiotherapy'], 'description': '8 sessions of 20-30 minutes each between 24 and 36 weeks of gestation with a physiotherapist or midwife', 'armGroupLabels': ['Rééducation']}, {'name': 'Written information about kegel exercises', 'type': 'OTHER', 'otherNames': ['kegel exercises'], 'description': 'Information about pelvic floor disorders prevention with personal pelvic floor exercises', 'armGroupLabels': ['Control', 'Rééducation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97405', 'city': 'Saint-Denis', 'state': 'Réunion', 'country': 'France', 'facility': 'CHR Réunion, CH Félix-Guyon', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '92141', 'city': 'Clamart', 'country': 'France', 'facility': 'CHU Antoine-Béclère', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '63058', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '30900', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '78105', 'city': 'Saint-Germain', 'country': 'France', 'facility': 'CH Poissy-Saint-Germain', 'geoPoint': {'lat': 48.25736, 'lon': 4.03264}}], 'overallOfficials': [{'name': 'Xavier FRITEL, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Réunion, CH Félix Guyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'collaborators': [{'name': 'CIC-EC Réunion', 'class': 'UNKNOWN'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}