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N/A N=276 Randomized Single-blind Prevention

Pulse Pressure and Post-epidural Fetal Heart Rate Changes

Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery

Enrolled (actual)
276
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Incidence of New-onset Category II or III Fetal Heart Rate Tracings — 72; 52 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Lactated Ringer's (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
MetroHealth Medical Center
Primary completion
Nov 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence of New-onset Category II or III Fetal Heart Rate Tracings
72; 52
SECONDARY
New Onset Hypotension (>20% Decrease in Systolic and/or Diastolic Blood Pressure)
48; 14
SECONDARY
Interventions to Correct Maternal Hypotension or Fetal Heart Rate Abnormalities (Position Change, Supplemental Oxygen, Vasopressor Support, Emergent Operative Delivery)
61; 25
SECONDARY
Adverse Events (Pulmonary Edema)
0; 0

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.

Eligibility Criteria

Inclusion Criteria

  • Singleton pregnancy with gestational age ≥ 35 weeks
  • Admission for delivery
  • Age 18 or older
  • Desires neuraxial analgesia in labor
  • No exclusion criteria
  • Maternal pulse pressure 1.0)
  • Maternal hypotension (as defined in secondary outcomes below) prior to epidural placement
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02565485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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