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Not Yet RecruitingNCT07272018

Maternal and Fetal Clinical Significance of Hypotension Following Labor Epidural Analgesia

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
480 (estimated)
Sponsor
The Chaim Sheba Medical Center · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHEREpidural 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.

Timeline

Start date
2025-12-01
Primary completion
2026-02-01
Completion
2026-03-01
First posted
2025-12-09
Last updated
2025-12-09

Source: ClinicalTrials.gov record NCT07272018. Inclusion in this directory is not an endorsement.

Maternal and Fetal Clinical Significance of Hypotension Following Labor Epidural Analgesia (NCT07272018) · Clinical Trials Directory