Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-27 @ 6:26 AM
Study NCT ID:
NCT07272018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal and Fetal Clinical Significance of Hypotension Following Labor Epidural Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015360', 'term': 'Analgesia, Epidural'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute and relative number of patients with any MAP (mean arterial pressure) < 65 mmHg', 'timeFrame': 'First 30 minutes after epidural placement', 'description': 'Hypotension after epidural placement'}], 'secondaryOutcomes': [{'measure': 'Absolute and relative number of patients with any MAP (mean arterial pressure) < 60, 55 mmHg', 'timeFrame': 'First 30 minutes after epidural placement', 'description': 'Hypotension after epidural placement'}, {'measure': 'Absolute and relative number of patients with any SBP (systolic blood pressure) < 90, 85, 80 mmHg', 'timeFrame': 'First 30 minutes after epidural placement', 'description': 'Hypotension after epidural placement'}, {'measure': 'Incidence of postepidural hypotension defined as ≥20% MAP (mean arterial pressure) drop', 'timeFrame': 'First 30 minutes after epidural placement', 'description': 'Hypotension after epidural placement'}, {'measure': 'Absolute and relative number of patients with ≥20% SBP (systolic blood pressure) drop', 'timeFrame': 'First 30 minutes after epidural placement', 'description': 'Hypotension after epidural placement'}, {'measure': 'Time-to-treatment of Hypotension (minutes)', 'timeFrame': 'First 30 minutes after epidural placement', 'description': 'The time interval between epidural placement and the treatment of hypotension by clinical staff'}, {'measure': 'Area under a MAP of 65, 60, 55 mmHg [mmHg x min]', 'timeFrame': 'First 30 minutes after epidural placement'}, {'measure': 'Absolute and relative number of patients with symptoms due to hypotension', 'timeFrame': 'First 30 minutes after epidural placement', 'description': 'Weakness, lightheadedness, fainting, dizziness, nausea, vomiting'}, {'measure': 'Absolute and relative number of patients with NRFHR (Non-reassuring fetal heart rate)', 'timeFrame': 'First 30 minutes after epidural placement'}, {'measure': 'Absolute and relative number of patients who received fluid bolus', 'timeFrame': 'First 30 minutes after epidural placement'}, {'measure': 'Absolute and relative number of patients who received vasopressor', 'timeFrame': 'First 30 minutes after epidural placement', 'description': 'Phenylephrine, ephedrine'}, {'measure': 'Absolute and relative numbers of patients who underwent urgent Cesarean section (Category 1 or 2 urgency) due to hypotension or NRFHR (non-reassuring fetal heart rate)', 'timeFrame': 'First 30 minutes after epidural placement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Labor Epidural Analgesia', 'Post-Epidural Hypotension', 'Maternal Hypotension', 'Fetal Heart Rate Abnormalities', 'Non-Reassuring Fetal Heart Rate', 'Obstetric Anesthesia'], 'conditions': ['Maternal Hypotension', 'Labor Epidural Analgesia', 'Fetal Heart Rate Abnormalities']}, 'referencesModule': {'references': [{'pmid': '339784', 'type': 'RESULT', 'citation': 'Ralston DH, Shnider SM. The fetal and neonatal effects of regional anesthesia in obstetrics. Anesthesiology. 1978 Jan;48(1):34-64. doi: 10.1097/00000542-197801000-00007. No abstract available.'}, {'pmid': '38283322', 'type': 'RESULT', 'citation': 'Ghidini A, Vanasche K, Cacace A, Cacace M, Fumagalli S, Locatelli A. Side effects from epidural analgesia in laboring women and risk of cesarean delivery. AJOG Glob Rep. 2023 Dec 12;4(1):100297. doi: 10.1016/j.xagr.2023.100297. eCollection 2024 Feb.'}, {'pmid': '15321239', 'type': 'RESULT', 'citation': 'Paech MJ, Godkin R, Webster S. Complications of obstetric epidural analgesia and anaesthesia: a prospective analysis of 10,995 cases. Int J Obstet Anesth. 1998 Jan;7(1):5-11. doi: 10.1016/s0959-289x(98)80021-6.'}, {'pmid': '29781504', 'type': 'RESULT', 'citation': 'Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.'}]}, 'descriptionModule': {'briefSummary': "The goal of this study is to learn how often blood pressure drops after an epidural for labor and how these drops may affect the parent and the baby. The study focuses on adults who give birth at term and choose to receive an epidural for pain relief.\n\nThe main questions the study aims to answer are:\n\nHow often does maternal blood pressure fall within 30 minutes after the epidural? When blood pressure falls, how often do participants need treatments such as fluids or medicines that raise blood pressure? Do changes in the baby's heart rate happen during this time, and do they need treatment? Are certain parent or labor factors linked to a higher chance of blood pressure drops? How often does an urgent cesarean delivery happen because of maternal low blood pressure or concerning fetal heart rate changes soon after the epidural?\n\nParticipants will not be asked to do anything different from usual care. Researchers will:\n\nReview routine vital signs recorded before and after the epidural Review treatments given, such as IV fluids or blood-pressure-raising medicines Review the baby's heart-rate monitoring Record delivery information, including whether an urgent cesarean was needed This study does not change clinical care in any way. It uses information already collected during standard labor and delivery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Laboring adults who receive epidural analgesia for pain relief at the labor and delivery unit of Sheba Medical Center, a large tertiary hospital in Israel. Participants represent people giving birth at term who choose epidural analgesia as part of their routine clinical care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* 37 weeks pregnant or more (term pregnancy)\n* in labor and choose to receive an epidural for pain relief\n* giving birth at Sheba Medical Center\n\nExclusion Criteria:\n\n* patients with a heart condition that requires special blood pressure management\n* medical conditions that prevent safe monitoring of blood pressure\n* missing or incomplete medical record data needed for the study\n* patient who do not receive an epidural during labor'}, 'identificationModule': {'nctId': 'NCT07272018', 'briefTitle': 'Maternal and Fetal Clinical Significance of Hypotension Following Labor Epidural Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'The Chaim Sheba Medical Center'}, 'officialTitle': 'Incidence and Clinical Significance of Maternal Hypotension After Labor Epidural Analgesia and Its Effects on Fetal Well-Being', 'orgStudyIdInfo': {'id': 'SMC-2210-25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laboring Participants Receiving Epidural Analgesia', 'description': 'This cohort includes adults in labor at Sheba Medical Center who choose to receive epidural analgesia for pain relief. All participants receive standard clinical care. Researchers will observe maternal blood pressure and fetal heart rate changes during the first 30 minutes after the epidural.', 'interventionNames': ['Other: Epidural Analgesia (Standard Clinical Care)']}], 'interventions': [{'name': 'Epidural Analgesia (Standard Clinical Care)', 'type': 'OTHER', 'description': 'Participants receive epidural analgesia for labor pain relief as part of routine clinical care at Sheba Medical Center. The epidural involves placement of an epidural catheter, a test dose, and a loading dose of local anesthetic according to hospital protocol. The study does not change how the epidural is performed. Researchers only observe maternal blood pressure and fetal heart rate after epidural placement.', 'armGroupLabels': ['Laboring Participants Receiving Epidural Analgesia']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maxim Glebov, Dr', 'role': 'CONTACT', 'email': 'hlebau@gmail.com', 'phone': '+972585893324'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Chaim Sheba Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Anesthesiologist in the Department of Anesthesiology', 'investigatorFullName': 'Maxim Glebov', 'investigatorAffiliation': 'The Chaim Sheba Medical Center'}}}}