Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT05560802
Status:
RECRUITING
Last Update Posted:
2024-10-22
First Post:
2022-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can the Use of a Next Generation Partograph Improve Neonatal Outcomes? (PICRINO)
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', 'interventionModelDescription': 'multicenter, stepped-wedge cluster randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-19', 'studyFirstSubmitDate': '2022-09-17', 'studyFirstSubmitQcDate': '2022-09-27', 'lastUpdatePostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse neonatal outcome', 'timeFrame': '12 weeks up to 18 months', 'description': 'a composite outcome of perinatal mortality and neonatal morbidity. Neonatal morbidity will include five-minute Apgar score \\<7, hypoxic ischemic encephalopathy II-III, intracranial hemorrhage, neonatal seizures, meconium aspiration syndrome, and admission to a neonatal unit.'}, {'measure': 'The rate of intrapartum cesarean section', 'timeFrame': '12 weeks up to 18 months', 'description': 'The rate of intrapartum cesarean section'}], 'secondaryOutcomes': [{'measure': 'Neonatal outcomes', 'timeFrame': '12 weeks up to 18 months', 'description': 'Five-minute Apgar score \\<7\n\nadmission to neonatal unit\n\nHypoxic ischemic encephalopathy II-III\n\nIntracranial hemorrhage\n\nNeonatal seizures\n\nMeconium aspiration syndrome\n\nFive-minute Apgar score \\<4\n\nPerinatal mortality\n\nneonatal mortality\n\nNeonatal infection\n\nNeonatal hypoglycemia\n\nNeonatal jaundice\n\nShoulder dystocia\n\nObstetric brachial plexus injury'}, {'measure': 'Obstetric outcomes', 'timeFrame': '12 weeks up to 18 months', 'description': 'Rates of spontaneous vaginal delivery\n\nRates of instrumental delivery\n\nIndications for intrapartum cesarean section\n\nRates of oxytocin use for augmentation of labor\n\nCervical dilation at onset of augmentation (centimeters)\n\nRates of adherence to oxytocin use recommendations\n\nRates of epidural use\n\nAmount of postpartum bleeding, ml\n\nRates of perineal laceration (grade II-IV)\n\nDuration of labor, minutes'}, {'measure': 'Childbirth experience (women and partners)', 'timeFrame': '12 weeks up to 18 months', 'description': 'interviews questionaries'}, {'measure': 'Provider experience of LCG', 'timeFrame': '12 weeks up to 18 months', 'description': 'interviews'}, {'measure': 'Economic evaluation', 'timeFrame': '12 weeks up to 18 months', 'description': 'Data on health care utilization for women Data on health care utilization for children'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neonatal outcomes', 'obstetric outcomes', 'labour care guide'], 'conditions': ['Neonatal Complication', 'Labor (Obstetrics)--Complications']}, 'referencesModule': {'references': [{'pmid': '30070803', 'type': 'BACKGROUND', 'citation': 'WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/'}, {'pmid': '33225484', 'type': 'BACKGROUND', 'citation': 'Vogel JP, Comrie-Thomson L, Pingray V, Gadama L, Galadanci H, Goudar S, Laisser R, Lavender T, Lissauer D, Misra S, Pujar Y, Qureshi ZP, Amole T, Berrueta M, Dankishiya F, Gwako G, Homer CSE, Jobanputra J, Meja S, Nigri C, Mohaptra V, Osoti A, Roberti J, Solomon D, Suleiman M, Robbers G, Sutherland S, Vernekar S, Althabe F, Bonet M, Oladapo OT. Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation. Birth. 2021 Mar;48(1):66-75. doi: 10.1111/birt.12511. Epub 2020 Nov 22.'}, {'pmid': '40036215', 'type': 'DERIVED', 'citation': "Isgren AR, Korsoski R, Abrahamsson T, Wendel SB, Kallen K, Lundborg L, Remaeus K, Thomas K, Wikstrom AK, Carlsson Y, Blomberg M. Can the use of a next generation partograph based on WHO's latest intrapartum care recommendations improve neonatal outcomes? (PICRINO) Study protocol for a stepped-wedge cluster randomized trial. PLoS One. 2025 Mar 4;20(3):e0316336. doi: 10.1371/journal.pone.0316336. eCollection 2025."}]}, 'descriptionModule': {'briefSummary': 'The overall aim is to evaluate the impact of the use of two different guidelines for monitoring labor progress, the WHOs LCG versus standard care, on neonatal and maternal outcomes. The hypothesis is that the use of LCG will reduce adverse neonatal outcomes and decrease the number of intrapartum Cesarean sections compared with standard care.\n\nSecondly, other perinatal interventions and complications will be compared between the LCG and standard care groups, as well as economic considerations. This will be investigated using a multicenter, stepped-wedge cluster randomized trial design.\n\nIn addition, the project will explore a series of quantitative and qualitative research questions to gain in-depth knowledge about experiences and perceptions about childbirth and the use of LCG. These research questions will be investigated using questionnaires, focus group and individual interviews with providers, partners and women that have gone through childbirth.', 'detailedDescription': "Study Title\n\nCan the use of a next generation partograph based on WHO's latest intrapartum care recommendations improve neonatal outcomes? A stepped-wedge cluster randomized trial (PICRINO).\n\nPrimary Objectives\n\nTo compare two different guidelines for monitoring labor progress, the the World Health Organization (WHO)'s Labour Care Guide (LCG) with standard care, and evaluate:\n\nAdverse neonatal outcome, a composite outcome of perinatal mortality and neonatal morbidity. Neonatal morbidity will include five-minute Apgar score \\<7, hypoxic ischemic encephalopathy II-III, intracranial hemorrhage, neonatal seizures, meconium aspiration syndrome, and admission to a neonatal unit.\n\nThe rate of intrapartum cesarean section.\n\nSecondary Objectives\n\nSecondary outcomes will be a composite of severe neonatal outcomes including five-minute Apgar score \\<4, hypoxic ischemic encephalopathy II-III, intracranial hemorrhage, neonatal seizures and meconium aspiration syndrome and other relevant neonatal outcomes.\n\nObstetric outcomes will be mode of delivery, oxytocin use, postpartum hemorrhage, perineal laceration (grade II-IV), duration of labor, women´s and partner´s experiences of childbirth, healthcare providers experiences of and compliance to LCG and economic considerations.\n\nStudy Design\n\nA multicenter, stepped-wedge cluster randomized trial.\n\nStudy Population\n\nAll women in active labor at participating delivery units in Sweden.\n\nPower analysis\n\nWith significance level 0.05, the power to detect the anticipated risk reduction (20%) would be \\>0.999.\n\nStudy Duration\n\n2023-2025"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-All women in active labor\n\nExclusion Criteria:\n\n-No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT05560802', 'briefTitle': 'Can the Use of a Next Generation Partograph Improve Neonatal Outcomes? (PICRINO)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': "Can the Use of a Next Generation Partograph Based on WHO's Latest Intrapartum Care Recommendations Improve Neonatal Outcomes? a Stepped-wedge Cluster Randomized Trial (PICRINO)", 'orgStudyIdInfo': {'id': 'Picrino2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Labour care guide', 'description': 'According to WHO guidelines', 'interventionNames': ['Other: WHOs Labour care guide']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Standard delivery care in Sweden'}], 'interventions': [{'name': 'WHOs Labour care guide', 'type': 'OTHER', 'description': 'Guidelines for monitoring labor progress, the WHOs LCG', 'armGroupLabels': ['Labour care guide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Eksjö', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Emma Lindqvist', 'role': 'CONTACT'}], 'facility': 'Eksjö höglandssjukhuset', 'geoPoint': {'lat': 57.66643, 'lon': 14.97205}}, {'city': 'Falun', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Emma Åkerlund', 'role': 'CONTACT'}], 'facility': 'Falu Lasarett', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}, {'city': 'Gällivare', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Malin Strand', 'role': 'CONTACT'}], 'facility': 'Gällivare sjukhus', 'geoPoint': {'lat': 67.13387, 'lon': 20.65278}}, {'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Radha Korsoski', 'role': 'CONTACT'}], 'facility': 'Göteborg Salgrenska Universitetssjukhuset', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Helsingborg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Tony Lavesson', 'role': 'CONTACT'}], 'facility': 'Helsingborgs lasarett', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'city': 'Huddinge', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Cecilia Johansson', 'role': 'CONTACT'}], 'facility': 'Huddinge Karolinska universitetssjukhus', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}, {'city': 'Hudiksvall', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Zoltan Zavaczki', 'role': 'CONTACT'}], 'facility': 'Hudiksvalls sjukhus', 'geoPoint': {'lat': 61.72744, 'lon': 17.10558}}, {'city': 'Jönköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Maria Wärnsberg', 'role': 'CONTACT'}], 'facility': 'Jönköping Länssjukhuset Ryhov', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}, {'city': 'Kalmar', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Maria Svenvik', 'role': 'CONTACT'}], 'facility': 'Länssjukhuset', 'geoPoint': {'lat': 56.66157, 'lon': 16.36163}}, {'city': 'Kristianstad', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Christina Vallen', 'role': 'CONTACT'}], 'facility': 'Kristianstad centralsjukhus', 'geoPoint': {'lat': 56.03129, 'lon': 14.15242}}, {'city': 'Linköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Eric Hildebrand', 'role': 'CONTACT'}], 'facility': 'Linköpings universitetssjukhus', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Lund', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Anna Bonnevier', 'role': 'CONTACT'}], 'facility': 'Lund Skånes universitetssjukhus', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Skellefteå', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Caisa Söderholm Edström', 'role': 'CONTACT'}], 'facility': 'Skellefteå Lasarett', 'geoPoint': {'lat': 64.75067, 'lon': 20.95279}}, {'city': 'Södertälje', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Malin Öndemark', 'role': 'CONTACT'}], 'facility': 'Södertälje Sjukhus', 'geoPoint': {'lat': 59.19554, 'lon': 17.62525}}, {'city': 'Södra Sunderbyn', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Malin Strand', 'role': 'CONTACT'}], 'facility': 'Sunderby sjukhus', 'geoPoint': {'lat': 65.65983, 'lon': 21.94004}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Katarina Remaeus', 'role': 'CONTACT'}], 'facility': 'BB Stockholm', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Hanna Åmark', 'role': 'CONTACT'}], 'facility': 'Stockholm Södersjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Umeå', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Linnea Åström', 'role': 'CONTACT'}], 'facility': 'Umeå Norrlands universitetssjukhus', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Mariella Öberg', 'role': 'CONTACT'}], 'facility': 'Akademiska sjukhuset', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Värnamo', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Elin Boozon', 'role': 'CONTACT'}], 'facility': 'Värnamo sjukhus', 'geoPoint': {'lat': 57.18604, 'lon': 14.04001}}, {'city': 'Västervik', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Maria Källman', 'role': 'CONTACT'}], 'facility': 'Västerviks sjukhus', 'geoPoint': {'lat': 57.7584, 'lon': 16.63733}}, {'city': 'Visby', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Åsa Hedqvist', 'role': 'CONTACT'}], 'facility': 'Visby Lasarett', 'geoPoint': {'lat': 57.64089, 'lon': 18.29602}}, {'city': 'Ystad', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Marie Carlsson', 'role': 'CONTACT'}], 'facility': 'Ystad Lasarett', 'geoPoint': {'lat': 55.42966, 'lon': 13.82041}}, {'city': 'Norrköping', 'state': 'Östergötland County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ulrica Ottosson', 'role': 'CONTACT'}], 'facility': 'Vrinnevisjukhuset', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}], 'centralContacts': [{'name': 'Marie Blomberg, Professor', 'role': 'CONTACT', 'email': 'marie.blomberg@liu.se', 'phone': '+4613288956'}, {'name': 'Anna Ramö Isgren, pHD', 'role': 'CONTACT', 'email': 'anna.ramo.isgren@regionostergotland.se'}], 'overallOfficials': [{'name': 'Marie Blomberg, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'At present we are not allowed to share anonymized data extracted from Swedish medical health registers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'The Swedish Research Council', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marie Blomberg', 'investigatorAffiliation': 'Linkoeping University'}}}}