Pulse Pressure Variability With Position Before EPIdural Analgesia (PP-PERI)

Predictive Value of a Postural Test on Pulse Pressure Variation During Labor With Epidural Analgesia on Fetal Heart Rate Abnormalities

Fetal heart rate abnormalities are common. Miller et al. have demonstrated that new onset fetal heart rate abnormalities after initial labor epidural dosing occur more frequently in women with a low admission pulse pressure than those with a normal admission pulse. The aim of the present study is to look for a statistical link between the occurrence of a fetal heart abnormality requiring an intervention and maternal hemodynamic factors (blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions: dorsal decubitus position and in the left lateral decubitus.

Study Overview

• Status: Completed
• Conditions: Epidural Analgesia; Labor
• Intervention / Treatment: Device: Nicom (TM)

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92140
    • AP-HP Hôpital Antoine Beclere
  • Levallois-Perret, France, 92300
    • Institut hospitalier franco-britannique
  • Paris, France, 75014
    • Institut Mutualiste Montsouris
  • Suresnes, France, 92150
    • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• pregnant women
• gestational age ≥ 36 weeks
• single eutrophic fetus
• wishing for epidural analgesia
• cervical dilatation less than or equal to 5 cm
• spontaneous labor
• scheduled for a vaginal delivery.

Non-inclusion Criteria:

• prematurity (< 36 weeks of amenorrhea) or post-term birth
• intention of induction of labour using oxytocin before epidural analgesia or prostaglandin
• contraindication to epidural analgesia
• history of hypertension or gravidic hypertension or heart disorder
• gestational diabetes
• foetal malformation or oligohydramnios or fetal growth abnormality
• fœtal macrosomia diagnosed by ultrasonic scanning
• hematocrit less than 20%

Exclusion Criteria

• induction of labour using oxytocin before epidural analgesia
• newborn weight > 4kg at birth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregnant women	Device: Nicom (TM); Heart rate, arterial pressure and cardiac output measurements (monitor NICOM) performed in the dorsal decubitus position and in the left lateral decubitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal heart rate	Fetal heart rate abnormalities occurring during the first hour of epidural analgesia and requiring an intervention. Relationship between maternal hemodynamic factors (heart rate, blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions (dorsal decubitus position and in the left lateral decubitus) and fetal heart rate abnormalities occurring during the first hour of epidural analgesia and requiring an intervention.	4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal heart rate	Fetal heart rate abnormalities occurring during the labor (>1 hour) and requiring an intervention. Comparison of the prognostic performance of pulse pressure and cardiac output to detect fetal heart rate abnormalities	4 days
Mode of delivery	Relationship between maternal hemodynamic factors (heart rate, blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions (dorsal decubitus position and in the left lateral decubitus) and mode of delivery.	4 days
Newborn heart rate, blood pressure, pulse pressure, and cardiac output	Relationship between maternal hemodynamic factors (heart rate, blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions (dorsal decubitus position and in the left lateral decubitus) and newborn health status.	4 days
Number of patients with hemodynamic abnormalities	Heart rate, blood pressure, pulse pressure, and cardiac output measured before and after epidural analgesia.	4 days

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Study Chair: Marc Fischler, MD PhD, Hopital Foch; Study Chair: Frédéric Mercier, MD PhD, AP-HP Hôpital A. Béclère

Publications and helpful links

General Publications

• Miller NR, Cypher RL, Nielsen PE, Foglia LM. Maternal pulse pressure at admission is a risk factor for fetal heart rate changes after initial dosing of a labor epidural: a retrospective cohort study. Am J Obstet Gynecol. 2013 Oct;209(4):382.e1-8. doi: 10.1016/j.ajog.2013.05.049. Epub 2013 Jun 13.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Epidural analgesia; Pulse pressure; Fetal heart rate abnormalities
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: 2016/31; 2016- A00846-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No