Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT07250620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Using 10min CTG in Fetal Monitoring Instead of 30min Monitoring in Low Resources Overcrowded Hospitals.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-23', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-23', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of a 10 minute CTG versus a standard 30-minute CTG in fetal monitoring and well being', 'timeFrame': 'Immediately after birth', 'description': 'Using fetal acidemia defined as (umbilical venous pH \\< 7.25) as reference in detecting fetal will being and comparing results with 10-min \\& 30-min CTG monitoring to evaluate diagnostic accuracy of both in detecting fetal acidemia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CTG', 'Fetal monitoring'], 'conditions': ['Normal Pregnancy', 'Labor Active Dilated Cm']}, 'referencesModule': {'references': [{'pmid': '37194903', 'type': 'RESULT', 'citation': 'Tomich MF, Leoni RS, Meireles PT, Petrini CG, Araujo Junior E, Peixoto AB. Accuracy of intrapartum cardiotocography in identifying fetal acidemia by umbilical cord blood analysis in low-risk pregnancies. Rev Assoc Med Bras (1992). 2023 May 15;69(6):e20221182. doi: 10.1590/1806-9282.20221182. eCollection 2023.'}, {'pmid': '28157275', 'type': 'RESULT', 'citation': 'Alfirevic Z, Devane D, Gyte GM, Cuthbert A. Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour. Cochrane Database Syst Rev. 2017 Feb 3;2(2):CD006066. doi: 10.1002/14651858.CD006066.pub3.'}, {'pmid': '28403965', 'type': 'RESULT', 'citation': 'Garabedian C, De Jonckheere J, Butruille L, Deruelle P, Storme L, Houfflin-Debarge V. Understanding fetal physiology and second line monitoring during labor. J Gynecol Obstet Hum Reprod. 2017 Feb;46(2):113-117. doi: 10.1016/j.jogoh.2016.11.005. Epub 2017 Jan 30.'}], 'seeAlsoLinks': [{'url': 'https://www.nice.org.uk/guidance/ng229', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Cardiotocography (CTG) is a cornerstone of intrapartum fetal monitoring but requires a minimum of 30 minutes for a reliable trace, creating a significant bottleneck in high-volume, low-resource settings like Egypt As it is time-consuming and resource intensive. This leads to delays in care and increased workload for healthcare providers. A shortened, yet accurate, CTG protocol could drastically improve workflow and resource allocation without compromising fetal safety.', 'detailedDescription': 'In Egypt, labor wards in tertiary hospitals are often overcrowded with limited CTG machines and midwives. The requirement of a minimum 30-minute CTG trace creates bottlenecks in care and increases staff workload. Previous studies suggest that the first 10 minutes of a CTG may capture the essential features of fetal well-being. If validated, a shortened CTG could improve efficiency in high-volume maternity units without compromising neonatal outcomes. Using umbilical venous pH as the gold standard for fetal acid-base status, this study will directly compare the diagnostic accuracy of a 10-minute versus a 30-minute CTG protocol in low-risk laboring women. The aim is to evaluate whether a 10-minute CTG tracing is non-inferior to the standard 30 minute CTG in fetal assessment and predicting fetal acid-base status (umbilical venous pH) in term, low-risk pregnancies during the active first stage of labor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All women who come to Women's Health Assiut university hospital in labor and meet the inclusion criteria after informed consent.", 'genderDescription': 'Pregnant women only with full term pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancy.\n* Gestational age ≥ 37 weeks.\n* Vertex presentation.\n* Active first stage of labor (cervical dilation ≥ 4 cm).\n* Low-risk pregnancy (no hypertension, diabetes, IUGR, or other significant complications).\n\nExclusion Criteria:\n\n* • Multiple gestation.\n\n * Known major fetal anomaly.\n * Non-vertex presentation.\n * Indication for continuous CTG (e.g., meconium-stained liquor, antepartum hemorrhage).\n * Maternal refusal.'}, 'identificationModule': {'nctId': 'NCT07250620', 'briefTitle': 'Comparison Between Using 10min CTG in Fetal Monitoring Instead of 30min Monitoring in Low Resources Overcrowded Hospitals.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Diagnostic Accuracy of 10-Minute Vs 30-Minute CTG in Intrapartum Fetal Monitoring.', 'orgStudyIdInfo': {'id': '10min CTG monitoring accuracy.'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women full term pregenancy in active stage of labor'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Soliman Mohamed Alazhary, Master', 'role': 'CONTACT', 'email': 'Soliman.alazhary@gmail.com', 'phone': '+20 1143883568'}, {'name': 'Seif Ahmed Ali, PHD', 'role': 'CONTACT', 'email': 'Seifali-2020@aun.edu.eg', 'phone': '+20 1004971596'}], 'overallOfficials': [{'name': 'Elwani Eldremey Elsenousy, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.Soliman Mohamed Alazhary', 'investigatorFullName': 'Soliman Mohamed Soliman Alazhary', 'investigatorAffiliation': 'Assiut University'}}}}