Maternal and Fetal Clinical Significance of Hypotension Following Labor Epidural Analgesia

NCT07272018 | Not Yet Recruiting

• 1 other identifier: SMC-2210-25
• Study Type: observational
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Maternal Hypotension; Labor Epidural Analgesia; Fetal Heart Rate Abnormalities

Keywords

Labor Epidural Analgesia; Post-Epidural Hypotension; Maternal Hypotension; Fetal Heart Rate Abnormalities; Non-Reassuring Fetal Heart Rate; Obstetric Anesthesia

Outcome Measures

Primary Outcomes (1)

• Absolute and relative number of patients with any MAP (mean arterial pressure) < 65 mmHg

  Hypotension after epidural placement

  First 30 minutes after epidural placement

Secondary Outcomes (11)

• Absolute and relative number of patients with any MAP (mean arterial pressure) < 60, 55 mmHg

  First 30 minutes after epidural placement

• Absolute and relative number of patients with any SBP (systolic blood pressure) < 90, 85, 80 mmHg

  First 30 minutes after epidural placement

• Incidence of postepidural hypotension defined as ≥20% MAP (mean arterial pressure) drop

  First 30 minutes after epidural placement

• Absolute and relative number of patients with ≥20% SBP (systolic blood pressure) drop

  First 30 minutes after epidural placement

• Time-to-treatment of Hypotension (minutes)

  First 30 minutes after epidural placement

Study Arms (1)

Laboring Participants Receiving Epidural Analgesia

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.

Other: Epidural Analgesia (Standard Clinical Care)

Interventions

Epidural Analgesia (Standard Clinical Care) OTHER

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.

Laboring Participants Receiving Epidural Analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Chaim Sheba Medical Center: lead

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Interventions

Analgesia, Epidural

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Central Study Contacts

Maxim Glebov, Dr

CONTACT

+972585893324; hlebau@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist in the Department of Anesthesiology

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 9, 2025
• Study Start: December 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share