N/A
N=276
Pulse Pressure and Post-epidural Fetal Heart Rate Changes
Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery
Bottom Line
View on ClinicalTrials.gov: NCT02565485 ↗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
| Outcome | Result | p-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
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.