Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 11:55 PM
Study NCT ID:
NCT06983535
Status:
TERMINATED
Last Update Posted:
2025-05-21
First Post:
2025-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Outpatient and Inpatient Use of a Cervical Balloon for Starting Labor in Low-Risk Pregnancies.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 358}}, 'statusModule': {'whyStopped': 'Slow inclusion rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fetal wellbeing', 'timeFrame': '12 hours', 'description': 'The primary outcome was foetal wellbeing assessed by cardiotocography (CTG) immediately after balloon insertion and balloon removal (12 hours after insertion). The CTG could be normal or not normal. The CTG was reported as not normal in case of a baseline rise, decelerations (even if they were not repeated decelerations) or decreased variability. The second CTG assessment was performed earlier in case of vaginal bleeding, fluid loss, onset of regular painful contractions, balloon expulsion or in any other case judged clinically relevant by the obstetrician'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['induction of labor', 'cervical ripening', 'balloon catheter'], 'conditions': ['Induction of Labor']}, 'referencesModule': {'references': [{'pmid': '27001034', 'type': 'BACKGROUND', 'citation': 'Alfirevic Z, Keeney E, Dowswell T, Welton NJ, Medley N, Dias S, Jones LV, Caldwell DM. Methods to induce labour: a systematic review, network meta-analysis and cost-effectiveness analysis. BJOG. 2016 Aug;123(9):1462-70. doi: 10.1111/1471-0528.13981. Epub 2016 Mar 22.'}], 'seeAlsoLinks': [{'url': 'https://www.europeristat.com/publications/european-perinatal-health-report-2015-2019/', 'label': 'European Perinatal Health Report: Core Indicators of the Health and Care of Pregnant Women and Babies in Europe from 2015 to 2019. Euro-Peristat'}]}, 'descriptionModule': {'briefSummary': "Why was this study done? About 20-30% of pregnancies involve labor being started artificially, known as induction. One way to do this is with a balloon catheter placed in the cervix, which helps prepare the body for labor. This mechanical method works just as well as using medication but may be safer for the baby, as it reduces the chances of the womb contracting too much (which can cause stress to the baby). Because it's safe and simple, this method could possibly be done at home instead of in the hospital.\n\nWhat was the aim of the study? The researchers wanted to compare how safe and effective this balloon method is when used at home (outpatient) versus in the hospital (inpatient). They also wanted to know how satisfied women were with each approach.\n\nHow was the study done? The study took place at four hospitals in Belgium between 2017 and 2023. It included women with healthy low risk pregnancies who were scheduled for induction for non-urgent reasons, such as being past their due date, having a large baby, or by personal choice after 38 weeks of pregnancy.\n\nThe women were randomly placed into two groups:\n\nOutpatient setting: going home after balloon placement.\n\nInpatient setting: staying in the hospital after balloon placement\\<\n\nThe main thing researchers measured was whether the baby's heart rate pattern (checked by CTG monitoring) was abnormal after 12 hours. They also looked at how the baby was born (vaginal birth or C-section), how long labor took, whether additional medicine was needed, pain management, and how satisfied the mothers were with the process.", 'detailedDescription': "Study Design and Approval\n\nThis was a randomised controlled trial - a scientific study designed to compare two groups as fairly as possible. It took place in four hospitals in Belgium:\n\nZiekenhuis Oost-Limburg (ZOL), Genk\n\nAZ Sint-Lucas, Brugge\n\nJessa Ziekenhuis, Hasselt\n\nUniversity Hospital Antwerp (UZA), Antwerp\n\nThe study ran from May 2017 to November 2023. It was carefully reviewed and approved by the Ethics Committee of ZOL Genk and the review boards of the other hospitals to make sure it followed strict ethical and safety standards.\n\nWho Could Take Part?\n\nWomen were eligible to join the study if they:\n\nWere over 18 years old\n\nWere pregnant with just one baby\n\nHad a baby in the head-down (cephalic) position\n\nHad a Bishop Score of 6 or less (indicating the cervix wasn't ready for labor)\n\nNeeded their labor to be induced for low-risk reasons, such as:\n\nBeing past their due date (post-term)\n\nSuspected large baby (macrosomia)\n\nPersonal request to induce labor after 38 weeks of pregnancy\n\nWomen were not allowed to join the study if they had any of the following:\n\nTwins or more (multiple pregnancy)\n\nPreterm premature rupture of membranes (water breaking too early)\n\nA baby not growing well (fetal growth restriction)\n\nA condition called placenta accreta spectrum (PAS)\n\nA previous cesarean section\n\nBaby not in head-down position\n\nGestational diabetes or high blood pressure during pregnancy\n\nLived more than 60 minutes away from the hospital\n\nAny other health issues (maternal or fetal) or reason that made vaginal birth unsafe\n\nHow Were Women Assigned to Groups? Women were told about the study by their doctor in the days leading up to labor induction. On the day of induction, a hospital doctor checked if they met the criteria. If they did, the woman was asked to sign a consent form to take part in the study.\n\nOnce enrolled, each woman was randomly assigned to one of two groups:\n\nInpatient group - stayed in the hospital after balloon insertion\n\nOutpatient group - went home after balloon insertion\n\nThe randomisation was done using a computer program, so neither the doctors nor patients could influence which group they were placed into. Because it was obvious who went home and who stayed, this study was not blinded.\n\nThe Induction Procedure All four hospitals had experience using mechanical methods to start labor. Before the study began, all staff received a brief training guide to ensure the procedure was done the same way in every hospital.\n\nHow the Balloon Was Inserted:\n\nA double-balloon catheter (Cook balloon) was gently inserted into the cervix using a special tool under direct view with a vaginal speculum.\n\nThe lower balloon (inside the uterus) was first filled with 20 ml of saline.\n\nThe balloon was pulled back so that it rested properly in the cervix.\n\nThen both balloons (one inside the uterus and one in the vagina) were gradually filled with saline up to 80 ml each.\n\nThe catheter was taped to the woman's thigh to keep it in place, but no tension or pulling was applied.\n\nAfter insertion, each woman was monitored for 2 hours using CTG to check the baby's heart rate and any contractions.\n\nIf the CTG after balloon insertion was not normal (e.g., slow heartbeat, signs of stress), the woman stayed in the hospital, even if she was in the outpatient group.\n\nOutpatient Group: Going Home If the CTG was normal, women in the outpatient group went home with the balloon still in place and were asked to return to the hospital 12 hours later, unless one of the following happened: their water broke (spontaneous rupture of membranes), they started having strong or painful contractions, the balloon came out or moved, they experienced non-tolerable pain or felt anxious, they simply didn't want to go home.\n\nBefore going home, every woman was given clear, written instructions about: when to come back early, what warning signs to look for, how to call the hospital, they also received a follow-up call from the doctor on duty 1-2 hours after leaving, to check how they were doing.\n\nAfter 12 Hours: Balloon Removal and Next Steps. Twelve hours after the balloon was placed (or sooner, if needed), the balloon was removed. At that time the Bishop Score was checked again to see if the cervix had softened or opened. A new CTG was performed to make sure the baby was doing well.\n\nWhat happened next depended on how the cervix looked: if the cervix was still not ready (Bishop Score ≤ 6):\n\n→ Labor was continued using prostaglandins (a medication to soften the cervix)\n\nIf the cervix was ready (Bishop Score \\> 6) and effaced (thinned out):\n\n→ Labor was started by breaking the water (amniotomy) and giving oxytocin to strengthen contractions\n\nIf the cervix was open but not thinned, doctors often chose oral or vaginal prostaglandins instead of breaking the water.\n\nAll clinical details were recorded by trained hospital staff.\n\nPrimary Outcome (Main Focus):\n\nThe baby's wellbeing as seen on the CTG (heart rate monitor) right after the balloon was inserted and again when it was removed (or sooner if problems occurred).\n\nSecondary Outcomes (Other Important Measures):\n\n1. Maternal Clinical Outcomes:\n\n How the baby was delivered (normal, assisted with vacuum or forceps, cesarean)\n\n Pain relief used (e.g., paracetamol, pethidine, epidural)\n\n Use of labor medications like oxytocin\n2. Process Outcomes:\n\n How long the entire induction process took:\n\n From hospital admission to discharge\n\n From balloon placement to delivery\n\n From balloon removal to delivery\n3. Maternal Satisfaction:\n\n Assessed using a detailed 16-question survey sent by email 1-2 days after delivery\n\n Topics included overall experience, comfort, timing, and whether they'd choose the same method again\n4. Maternal Health Concerns:\n\nPossible complications like:\n\nUterine hyperstimulation (too many contractions)\n\nPlacental abruption (placenta detaching early)\n\nInfections needing antibiotics\n\nDoctors also recorded why some women needed C-sections or assisted births."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* women \\>18 years of age with singleton pregnancies, cephalic presentation and a unfavourable cervix requiring priming (Bishop Score ≤ 6) that needed an IOL for low risk indications: post-term, macrosomia, patient's preference (\\> 38 0/7 weeks of gestational age).\n\nExclusion Criteria:\n\n* : multiple pregnancies, preterm premature rupture of membranes (pPROM), foetal growth restriction (FGR), placenta-accreta spectrum (PAS), previous C-Section(s), non-cephalic presentation, gestational diabetes, hypertensive disorders of pregnancy, living at \\>60 minutes from the hospital, any other maternal or foetal morbidity, any other contraindication to vaginal birth."}, 'identificationModule': {'nctId': 'NCT06983535', 'acronym': 'Cook', 'briefTitle': 'Comparing Outpatient and Inpatient Use of a Cervical Balloon for Starting Labor in Low-Risk Pregnancies.', 'organization': {'class': 'OTHER', 'fullName': 'Ziekenhuis Oost-Limburg'}, 'officialTitle': 'Induction of Labor (IOL) Using Cervical Double-balloon (Cook Catheter) in Outpatient Versus Inpatient Setting (COOK Study): a Multicentre, Randomised Controlled Trial.', 'orgStudyIdInfo': {'id': 'GYN2016.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Inpatient', 'description': 'Patient in this arm were randomized to stay in the hospital during cervical balloon ripening', 'interventionNames': ['Device: cervical balloon catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Outpatient', 'description': 'Patients in this arm were randomized to ambulant home setting during cervical ripening', 'interventionNames': ['Device: cervical balloon catheter']}], 'interventions': [{'name': 'cervical balloon catheter', 'type': 'DEVICE', 'description': 'Patients will be randomized to inpatient or outpatient setting while having the cervical ripening balloon catheter', 'armGroupLabels': ['Inpatient', 'Outpatient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Antwerp', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'University Hospitals Antwerp', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '3500', 'city': 'Hasselt', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '8000', 'city': 'Bruges', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'AZ Sint Lucas', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}], 'overallOfficials': [{'name': 'Zoe Pieters', 'role': 'STUDY_CHAIR', 'affiliation': 'Data Science Institute, Hasselt University, Diepenbeek, Belgium.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': '05/2017-11/2043', 'ipdSharing': 'YES', 'description': 'Data regarding the different outcomes', 'accessCriteria': 'Only the central study team will have access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'AZ Sint-Lucas Brugge', 'class': 'OTHER'}, {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, {'name': 'Jessa Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}