Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-28 @ 4:56 PM
Study NCT ID:
NCT05622968
Status:
TERMINATED
Last Update Posted:
2025-01-17
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outpatient Induction of Labour Using Intracervical Foley Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D062885', 'term': 'Urinary Catheters'}, {'id': 'D015232', 'term': 'Dinoprostone'}], 'ancestors': [{'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011458', 'term': 'Prostaglandins E'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'whyStopped': 'Poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Induction of labour-delivery interval', 'timeFrame': 'Induction of labour (intravaginal prostaglandin) to delivery', 'description': 'The mean interval between the start of inpatient cervical ripening and delivery (from the start of cervical ripening with Dinoprostone to the delivery of the baby)'}], 'secondaryOutcomes': [{'measure': 'Success rate of induction of labour within 12 hours', 'timeFrame': 'From the start of inpatient cervical ripening and delivery', 'description': 'The percentage of vaginal delivery within 12 hours of inpatient cervical ripening'}, {'measure': 'Success rate of induction of labour within 24 hours', 'timeFrame': 'From the start of inpatient cervical ripening and delivery', 'description': 'The percentage of vaginal delivery within 24 hours of inpatient cervical ripening'}, {'measure': 'Delivery outcome', 'timeFrame': 'Induction to delivery', 'description': 'Percentage of caesarean section and instrumental delivery'}, {'measure': 'Adverse event', 'timeFrame': 'Induction to delivery', 'description': 'Incidence of uterine tachysystole and hyperstimulation'}, {'measure': 'Labour augmentation', 'timeFrame': 'Induction to delivery', 'description': 'Duration and maximum oxytocin dose used for labour augmentation'}, {'measure': 'Maximum pain recorded', 'timeFrame': 'Induction to delivery', 'description': 'Maximum recorded contraction pain during cervical ripening (using Visual Analogue Scale of 10)'}, {'measure': 'Incidence of chorioamnionitis', 'timeFrame': 'Induction to 24 hours after delivery', 'description': 'maternal temperature is greater than or equal to 39.0°C or when the maternal temperature is 38.0-38.9°C and one additional clinical risk factor is present'}, {'measure': 'Analgesia requirement', 'timeFrame': 'Induction to delivery', 'description': 'Prevalence of analgesia required during induction of labour'}, {'measure': 'Postpartum hemorrhage', 'timeFrame': 'Delivery to 24 hours after delivery', 'description': 'Primary postpartum haemorrhage (blood loss of more than 500mls within 24 hours of delivery)'}, {'measure': 'Neonatal Apgar score', 'timeFrame': 'Delivery to 10 minutes after birth', 'description': 'Incidence of low Apgar score (less than 7) at 5 minutes after delivery'}, {'measure': 'Neonatal intubation', 'timeFrame': 'Delivery to 30 minutes after birth', 'description': 'Incidence of neonates requiring intubation'}, {'measure': 'Neonatal seizure', 'timeFrame': 'Delivery to 24 hours after birth', 'description': 'Incidence of neonate with seizure'}, {'measure': 'Neonatal complication', 'timeFrame': 'Delivery to 24 hours after birth', 'description': 'Admission to the Neonatal Intensive Care Unit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['outpatient induction', 'Foley catheter'], 'conditions': ['Pregnancy Related', 'Induction of Labor Affected Fetus / Newborn']}, 'referencesModule': {'references': [{'pmid': '27513897', 'type': 'BACKGROUND', 'citation': 'Sharp AN, Stock SJ, Alfirevic Z. Outpatient induction of labour in the UK: a survey of practice. Eur J Obstet Gynecol Reprod Biol. 2016 Sep;204:21-3. doi: 10.1016/j.ejogrb.2016.06.023. Epub 2016 Jul 30.'}, {'type': 'RESULT', 'citation': 'Royal College of Obstetricians and Gynaecologists. Evidence-based Clinical Guideline No. 9. Induction of labour'}, {'pmid': '19623003', 'type': 'RESULT', 'citation': 'ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.'}, {'pmid': '24099451', 'type': 'RESULT', 'citation': 'Leduc D, Biringer A, Lee L, Dy J; CLINICAL PRACTICE OBSTETRICS COMMITTEE; SPECIAL CONTRIBUTORS. Induction of labour. J Obstet Gynaecol Can. 2013 Sep;35(9):840-857. doi: 10.1016/S1701-2163(15)30842-2. English, French.'}, {'pmid': '20687092', 'type': 'RESULT', 'citation': 'Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Different methods for the induction of labour in outpatient settings. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007701. doi: 10.1002/14651858.CD007701.pub2.'}, {'pmid': '28901007', 'type': 'RESULT', 'citation': 'Vogel JP, Osoti AO, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Pharmacological and mechanical interventions for labour induction in outpatient settings. Cochrane Database Syst Rev. 2017 Sep 13;9(9):CD007701. doi: 10.1002/14651858.CD007701.pub3.'}, {'pmid': '32605542', 'type': 'RESULT', 'citation': "Dong S, Khan M, Hashimi F, Chamy C, D'Souza R. Inpatient versus outpatient induction of labour: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2020 Jun 30;20(1):382. doi: 10.1186/s12884-020-03060-1."}, {'pmid': '34214801', 'type': 'RESULT', 'citation': 'Croll DMR, Hoge PC, Verhoeven CJM, de Boer MA, Bloemenkamp KWM, de Heus R. Changes in local protocols on inpatient cervical priming and introduction of outpatient priming: A nationwide survey in the Netherlands. Eur J Obstet Gynecol Reprod Biol. 2021 Aug;263:148-152. doi: 10.1016/j.ejogrb.2021.06.004. Epub 2021 Jun 10.'}, {'pmid': '26365009', 'type': 'RESULT', 'citation': 'Amorosa JM, Stone JL. Outpatient cervical ripening. Semin Perinatol. 2015 Oct;39(6):488-94. doi: 10.1053/j.semperi.2015.07.014. Epub 2015 Sep 11.'}, {'pmid': '27078202', 'type': 'RESULT', 'citation': 'Kruit H, Heikinheimo O, Ulander VM, Aitokallio-Tallberg A, Nupponen I, Paavonen J, Rahkonen L. Foley catheter induction of labor as an outpatient procedure. J Perinatol. 2016 Aug;36(8):618-22. doi: 10.1038/jp.2016.62. Epub 2016 Apr 14.'}, {'pmid': '11704164', 'type': 'RESULT', 'citation': 'Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.'}, {'pmid': '29211328', 'type': 'RESULT', 'citation': 'Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG. 2018 Aug;125(9):1086-1095. doi: 10.1111/1471-0528.15047. Epub 2018 Jan 10.'}, {'pmid': '31793372', 'type': 'RESULT', 'citation': 'Stephenson E, Borakati A, Simpson I, Eedarapalli P. Foley catheter for induction of labour: a UK observational study. J Obstet Gynaecol. 2020 Nov;40(8):1064-1068. doi: 10.1080/01443615.2019.1676213. Epub 2019 Dec 3.'}, {'pmid': '24635460', 'type': 'RESULT', 'citation': 'Turnbull D, Adelson P, Oster C, Bryce R, Fereday J, Wilkinson C. Psychosocial outcomes of a randomized controlled trial of outpatient cervical priming for induction of labor. Birth. 2013 Jun;40(2):75-80. doi: 10.1111/birt.12035. Epub 2013 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'Prospective quasi-experimental study between a study population who will receive outpatient induction of labour using intracervical Foley catheter, followed by the inpatient induction using intravaginal prostaglandin and a control group of women with similar characteristics undergoing inpatient labour induction with intravaginal prostaglandin (standard management)', 'detailedDescription': 'The study will be conducted among pregnant women in 2 to 5th pregnancy who have no significant risk factors and planned for induction of labour. The eliiable women will be recruited from 4 health clinics within the district (of Kemaman, Malaysia) and located within 20 km from the hospital.\n\nWilling participants will be seen in the hospital at the planned induction date and reassessed. Should they be suitable for induction of labour using Foley catheter on outpatient basis, a 18G Foley catheter will be inserted into the cervical canal and the balloon inflated with sterile water (60 mls). The fetal well being will be assessed and the women allowed to go home with instruction related to the induction and the study.\n\nThose who do not enter the active phase of labour will be admitted to the ward 24 hours later and will undergo inpatient induction of labour using intravaginal prostaglandin (Dinoprostone) according to the local protocol.\n\nThese women will be compared with a control group comprising of women with similar characteristics and undergo inpatient induction of labour with intravaginal Dinoprostone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'All low risk pregnant women with obstetric indication for induction of labour at term', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 year old\n* Singleton pregnancy\n* Cephalic presentation\n* Multiparous women in their 2nd to 5th pregnancy (Para 1 to 4)\n* Gestational age between 37+0 and 41+0 weeks.\n* No previous uterine surgery (lower segment caesarean section, upper segment caesarean section, myomectomy\n* Resides within 30 minutes drive from Hospital Kemaman\n* Has access to a telephone\n* Has reliable transportation (i.e. able to get to the hospital immediately without the need of ambulance)\n* Acceptance of participation by the signing of a written consent.\n\nExclusion Criteria:\n\n* Pregnancy with non-cephalic presentation\n* Prior cesarean delivery\n* Gestational hypertension or preeclampsia on 2 or more medications\n* Diabetes in pregnancy on high dose medication(s); insulin of more than 60 units per day or combination of insulin and oral hypoglycemic agent\n* Low lying placenta or placenta praevia\n* Rupture of amniotic membrane\n* Primiparae and grandmultiparae (para 5 or more)\n* Multiple pregnancy\n* Fetal death\n* Fetal anomalies: defined as the presence of a major fetal anomaly of any organ system\n* Fetal growth restriction: defined as an ultrasound derived estimated fetal weight less than the 10th percentile for gestational age\n* Suspected macrosomia: defined as an ultrasound derived estimated fetal weight of more than 90th centile for gestational age\n* Oligohydramnios: ultrasound measured amniotic fluid index (AFI) less than the 10th percentile for gestational age\n* Polyhydramnios: defined as an AFI of 24 cm or greater or a single deepest vertical pocket of 8 cm or greater\n* Latex allergy\n* Contraindication to induction of labor\n* Evidence of active phase of labor'}, 'identificationModule': {'nctId': 'NCT05622968', 'acronym': 'OFC', 'briefTitle': 'Outpatient Induction of Labour Using Intracervical Foley Catheter', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Kemaman'}, 'officialTitle': 'Outpatient Cervical Ripening With Foley Catheter for Induction of Labour in Low Risk Women: a Quasi-experimental Study (OFC Study)', 'orgStudyIdInfo': {'id': 'NMRR ID-22-00349-EQQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Women who are planned for elective delivery for obstetric indication(s) and undergo outpatient induction of labour using Foley catheter', 'interventionNames': ['Device: Foley catheter', 'Drug: Intravaginal prostaglandin E2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Women who are planned for elective delivery for obstetric indication(s) and undergo inpatient induction of labour using intravaginal prostaglandin', 'interventionNames': ['Drug: Intravaginal prostaglandin E2']}], 'interventions': [{'name': 'Foley catheter', 'type': 'DEVICE', 'otherNames': ['urinary catheter'], 'description': 'Insertion of 18G Foley catheter into the cervical canal and inflating the balloon to 60 mls using sterile water', 'armGroupLabels': ['Intervention']}, {'name': 'Intravaginal prostaglandin E2', 'type': 'DRUG', 'otherNames': ['Dinoprostone'], 'description': 'Insertion of intravaginal Dinoprostone', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24000', 'city': 'Kampong Kemaman', 'state': 'Terengganu', 'country': 'Malaysia', 'facility': 'Hospital Kemaman', 'geoPoint': {'lat': 4.23333, 'lon': 103.45}}], 'overallOfficials': [{'name': 'Zahar Zakaria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Kemaman'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share for now'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Kemaman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Head of Obstetric & Gynecology Department, Senior Consultant', 'investigatorFullName': 'Zahar Azuar Zakaria', 'investigatorAffiliation': 'Hospital Kemaman'}}}}