Maternal and Fetal Clinical Significance of Hypotension Following Labor Epidural Analgesia

ConditionsMaternal Hypotension Labor Epidural Analgesia Fetal Heart Rate Abnormalities

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorThe Chaim Sheba Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Epidural Analgesia (Standard Clinical Care)
Other intervention
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.

Treatment groups

480 Participants

are divided into 1 treatment group

Group A: Laboring Participants Receiving Epidural Analgesia1 intervention