CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 276 enrolled
Drug / intervention
Lactated Ringer'sdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02565485
NCT02565485N/ACompleted

Pulse Pressure-guided IV Fluid Preload to Prevent Post-epidural Fetal Heart Rate (FHR) Changes: a Randomized Controlled Trial

MetroHealth Medical Center·interventional·Posted Oct 1, 2015·Updated Jul 9, 2018

In Brief

A clinical study evaluating Lactated Ringer's for Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery. Completed, enrolled 276 participants across 1 site.

Detailed Summary

Epidural anesthesia, the most common method of pain control in labor, can contribute to alterations in maternal blood pressure and/or fetal heart rate changes. As a result, the administration of an IV fluid bolus ("preload") is standard prior to epidural placement. However, the optimal volume of preload is unknown and no clinical trials have evaluated a risk-factor based approach to dosing. Studies in the critical care, trauma, and obstetric literature have suggested that a narrow pulse pressure (difference between systolic and diastolic blood pressures) is a marker of reduced intravascular volume status and may identify women at a higher risk for new onset fetal heart rate changes after epidural placement. Therefore, the purpose of this study is to assess if an increased IV fluid preload bolus among women with a narrow pulse pressure reduces the risk of new onset fetal heart rate changes after epidural placement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 1, 2015
Enrollment StartSep 1, 2015
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.8 years ago

Interventions

Lactated Ringer'sdrug

1500 cc of IV Fluid (crystalloid) used for preload prior to epidural administration in the treatment arm. Control arm receives 500 cc.