Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-01-03 @ 11:16 PM
Study NCT ID:
NCT07265518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007291', 'term': 'Inosine Monophosphate'}], 'ancestors': [{'id': 'D007292', 'term': 'Inosine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 258}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-10-01', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Observational study: Determine patients' reasons for refusing to participate in the randomized study via an internal questionnaire", 'timeFrame': '72 hours'}, {'measure': '8. Observational study: Compare maternal satisfaction with induction between the "patients randomized to hospitalization" and "non-randomized patients (hospitalized)" groups via EXIT questionnaire', 'timeFrame': '72 hours'}], 'primaryOutcomes': [{'measure': 'compare the duration of induction and labor between outpatient and inpatient care.', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'Compare maternal satisfaction from induction to delivery between the two groups outpatient and inpatient via EXIT questionnaire', 'timeFrame': '48 hours'}, {'measure': 'Compare maternal morbidity and mortality between the two groups outpatient and inpatient', 'timeFrame': '48 hours'}, {'measure': 'Compare neonatal morbidity and mortality between the two groups outpatient and inpatient', 'timeFrame': '48 hours'}, {'measure': 'Compare the number of hospital beds freed up and the number of concurrent induction in the department', 'timeFrame': '24 hours'}, {'measure': 'Compare medico-economic evaluation (cost-consequence analysis) from a collective perspective and with a time horizon of one month between the two groups outpatient and inpatient', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['outpatient labor induction', 'low-risk pregnant women', 'transcervical catheter'], 'conditions': ['Pregnant Women']}, 'descriptionModule': {'briefSummary': 'The aim goal of this study is to compare the duration of induction and labor between outpatient and inpatient care in low-risk pregnant women.\n\nThe secondary objectives are to compare between the two groups the maternal satisfaction from induction to delivery, the maternal and neonatal morbidity and mortality, impact on service organization and a medico-economic evaluation (cost-consequence analysis) from a collective perspective and with a time horizon of one month For women who do not agree to take part in the randomized study, an observational study will be proposed to them in order to collect the reason for their refusal and their maternal satisfaction.\n\nResearchers will compare the return home with conventional hospitalization\n\nPatients presenting with a singleton pregnancy and with an indication for induction of labor will be proposed to participate in the study.\n\nIf the pregnant woman refuses to participate in the randomized study, she will be invited to take part in the observational study.\n\nFor women who accept, a fetal heart rate recording (FHRR) is made prior to balloon insertion. If there is no fetal heart rhythm abnormality (FHR), the double balloon catheter is inserted by a midwife. A further ERCF is performed to ensure that the procedure is well tolerated.\n\nIn the absence of metrorrhagia, fetal heart rate abnormalities, rupture of the water sac or uterine hypertonia/hyperkinesia, the patient will then be randomized to either the in-patient or out-patient arm. The patient will either be placed in a room or go home.\n\nIn both cases, the balloon will be removed after 24 hours in hospital in the absence of spontaneous labor, and the patient will be referred to the delivery room for water breakage and/or oxytocin infusion for induction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female gender', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant woman with singleton pregnancy in cephalic presentation\n* Term ≥ 37SA+0d\n* Age ≥ 18 years\n* Affiliated or beneficiary of a social security scheme\n* No severe maternal/neonatal pathology (severe pre-eclampsia, intra-uterine growth retardation, etc.)\n* Indication for balloon induction\n* Bishop score \\<6\n* Home-hospital distance ≤ 30 minutes' drive\n* Presence of a family member at the woman's side to help her return home\n\nExclusion Criteria:\n\n* Scarred uterus\n* Fetal heart rhythm abnormalities\n* Rupture of membranes\n* Death in utero\n* Placenta previa or adherent placenta (accreta or percreta)\n* Maternal respiratory, cardiac, hepatic, renal, digestive or decompensated psychiatric pathology\n* Anamnios\n* Patient under guardianship, curatorship and/or safeguard of justice"}, 'identificationModule': {'nctId': 'NCT07265518', 'acronym': 'OutCRIB', 'briefTitle': 'Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB', 'orgStudyIdInfo': {'id': 'RC24_0036'}, 'secondaryIdInfos': [{'id': '2024-A02122-45', 'type': 'REGISTRY', 'domain': 'RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Outpatient', 'description': 'patients randomized to this arm will go home until labour or 24 hours after balloon insertion', 'interventionNames': ['Other: Outpatient']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Inpatient', 'description': 'patients randomized to this arm will stay at hospital', 'interventionNames': ['Other: Inpatient']}, {'type': 'NO_INTERVENTION', 'label': 'observationnal study', 'description': "patients refusing to be randomized will be able to enter this cohort without their care affecting the site's usual clinical practice"}], 'interventions': [{'name': 'Outpatient', 'type': 'OTHER', 'description': 'Women return at home', 'armGroupLabels': ['Outpatient']}, {'name': 'Inpatient', 'type': 'OTHER', 'description': 'Women stay at hospital', 'armGroupLabels': ['Inpatient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'Loire Atlantique', 'country': 'France', 'contacts': [{'name': 'Vincent DOCHEZ, Dr', 'role': 'CONTACT', 'email': 'vincent.dochez@chu-nantes.fr', 'phone': '0240083177'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '85000', 'city': 'La Roche-sur-Yon', 'state': 'vendée', 'country': 'France', 'contacts': [{'name': 'Emelyne Dr LEFIZELIER', 'role': 'CONTACT', 'email': 'Emelyne.lefizelier@ght85.fr', 'phone': '0251446161'}], 'facility': 'CHD Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}], 'centralContacts': [{'name': 'MARION GAUTIER', 'role': 'CONTACT', 'email': 'marion.gautier@chu-nantes.fr', 'phone': '+33253526204'}], 'overallOfficials': [{'name': 'Vincent DOCHEZ, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}