Maternal and Fetal Clinical Significance of Hypotension Following Labor Epidural Analgesia

Official title

Incidence and Clinical Significance of Maternal Hypotension After Labor Epidural Analgesia and Its Effects on Fetal Well-Being

Overview

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. The main questions the study aims to answer are: How 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? Participants will not be asked to do anything different from usual care. Researchers will: Review 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.

Interventions

• Other Epidural Analgesia (Standard Clinical Care)
  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.

Primary outcome measures

• Absolute and relative number of patients with any MAP (mean arterial pressure) < 65 mmHg [Time frame: First 30 minutes after epidural placement]

Secondary outcome measures (11)

• Absolute and relative number of patients with any MAP (mean arterial pressure) < 60, 55 mmHg [Time frame: First 30 minutes after epidural placement]
• Absolute and relative number of patients with any SBP (systolic blood pressure) < 90, 85, 80 mmHg [Time frame: First 30 minutes after epidural placement]
• Incidence of postepidural hypotension defined as ≥20% MAP (mean arterial pressure) drop [Time frame: First 30 minutes after epidural placement]
• Absolute and relative number of patients with ≥20% SBP (systolic blood pressure) drop [Time frame: First 30 minutes after epidural placement]
• Time-to-treatment of Hypotension (minutes) [Time frame: First 30 minutes after epidural placement]
• Area under a MAP of 65, 60, 55 mmHg [mmHg x min] [Time frame: First 30 minutes after epidural placement]
• Absolute and relative number of patients with symptoms due to hypotension [Time frame: First 30 minutes after epidural placement]
• Absolute and relative number of patients with NRFHR (Non-reassuring fetal heart rate) [Time frame: First 30 minutes after epidural placement]
• Absolute and relative number of patients who received fluid bolus [Time frame: First 30 minutes after epidural placement]
• Absolute and relative number of patients who received vasopressor [Time frame: First 30 minutes after epidural placement]
• 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) [Time frame: First 30 minutes after epidural placement]

Eligibility criteria

Inclusion criteria

• 18 years of age or older
• 37 weeks pregnant or more (term pregnancy)
• in labor and choose to receive an epidural for pain relief
• giving birth at Sheba Medical Center

Exclusion criteria

• patients with a heart condition that requires special blood pressure management
• medical conditions that prevent safe monitoring of blood pressure
• missing or incomplete medical record data needed for the study
• patient who do not receive an epidural during labor

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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 339784
• 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 38283322
• 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 15321239
• 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. PMID 29781504

Identifiers

NCT: NCT07272018 · SMC-2210-25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗