NCT02565485

Pulse Pressure and Post-epidural Fetal Heart Rate Changes

Completed NA Results posted Last updated 9 July 2018

What this trial tests

NA trial testing Lactated Ringer's in Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery in 276 participants. Completed in 1 November 2016.

Timeline

1 September 2015

Primary endpoint
1 November 2016

1 November 2016

Quick facts

Lead sponsor	MetroHealth Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	276
Start date	1 September 2015
Primary completion	1 November 2016
Estimated completion	1 November 2016
Sites	1 location across United States

Drugs / interventions tested

• Lactated Ringer's

Conditions studied

• Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery — all drugs for Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery →

Sponsor

MetroHealth Medical Center

Who can join

Adults 18 to 50, female only, with Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of New-onset Category II or III Fetal Heart Rate Tracings Primary · First 60 minutes following epidural placement

Each fetal heart rate tracing was evaluated in 15 min increments from the completion of epidural placement and initial dose administration. ACOG Category I, II, and III was assigned to each 15 min increment.

Group	Value	95% CI
Standard IV Preload	72
Volume Replacement IV Preload	52

New Onset Hypotension (>20% Decrease in Systolic and/or Diastolic Blood Pressure) Secondary · First 60 minutes following epidural placement

Group	Value	95% CI
Standard IV Preload	48
Volume Replacement IV Preload	14

Interventions to Correct Maternal Hypotension or Fetal Heart Rate Abnormalities (Position Change, Supplemental Oxygen, Vasopressor Support, Emergent Operative Delivery) Secondary · First 60 minutes following epidural placement

Group	Value	95% CI
Standard IV Preload	61
Volume Replacement IV Preload	25

Adverse Events (Pulmonary Edema) Secondary · Duration of intrapartum course

Pulmonary edema occurring after preload bolus through delivery was considered an adverse event.

Group	Value	95% CI
Standard IV Preload	0
Volume Replacement IV Preload	0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Maternal Pulse Pressure and the Risk of Postepidural Complications: A Randomized Controlled Trial.
   Lappen JR, Myers SA, Bolen N, Mercer BM, et al · · 2017 · cited 10× · PMID 29112650 · DOI 10.1097/aog.0000000000002326