Maternal and Fetal Clinical Significance of Hypotension Following Labor Epidural Analgesia

Sheba Medical Center

Status: Not yet enrolling

Conditions: Maternal Hypotension; Fetal Heart Rate Abnormalities; Labor Epidural Analgesia

Treatments: Other: Epidural Analgesia (Standard Clinical Care)

Study type: Observational

Funder types: Other

Identifiers

NCT07272018

SMC-2210-25

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

480 participants in 1 patient group

Laboring Participants Receiving Epidural Analgesia

Description:

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.

Treatment:

Other: Epidural Analgesia (Standard Clinical Care)