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NCT Number: NCT07272018

Maternal and Fetal Clinical Significance of Hypotension Following Labor Epidural Analgesia

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: First 30 minutes after epidural placement

    Hypotension after epidural placement

Secondary outcomes

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

    Time frame: First 30 minutes after epidural placement

    Hypotension after epidural placement

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

    Time frame: First 30 minutes after epidural placement

    Hypotension after epidural placement

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

    Time frame: First 30 minutes after epidural placement

    Hypotension after epidural placement

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

    Time frame: First 30 minutes after epidural placement

    Hypotension after epidural placement

  5. Time-to-treatment of Hypotension (minutes)

    Time frame: First 30 minutes after epidural placement

    The time interval between epidural placement and the treatment of hypotension by clinical staff

  6. Area under a MAP of 65, 60, 55 mmHg [mmHg x min]

    Time frame: First 30 minutes after epidural placement

  7. Absolute and relative number of patients with symptoms due to hypotension

    Time frame: First 30 minutes after epidural placement

    Weakness, lightheadedness, fainting, dizziness, nausea, vomiting

  8. Absolute and relative number of patients with NRFHR (Non-reassuring fetal heart rate)

    Time frame: First 30 minutes after epidural placement

  9. Absolute and relative number of patients who received fluid bolus

    Time frame: First 30 minutes after epidural placement

  10. Absolute and relative number of patients who received vasopressor

    Time frame: First 30 minutes after epidural placement

    Phenylephrine, ephedrine

  11. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Maxim Glebov, Dr

CONTACT

[email protected]

+972585893324

Sponsors and collaborators

Lead sponsor

The Chaim Sheba Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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