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

Primary Purpose

Labor, Epidural Analgesia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nicom (TM)
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Labor focused on measuring Fetal heart rate abnormalities, Pregnancy, Epidural analgesia, Pulse pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • AP-HP Hopital Antoine Beclere
  • Institut Hospitalier Franco-Britannique
  • Institut Mutualiste Montsouris
  • Hopital Foch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pregnant women

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
Number of patients with hemodynamic abnormalities
Heart rate, blood pressure, pulse pressure, and cardiac output measured before and after epidural analgesia.

Full Information

First Posted
March 21, 2017
Last Updated
August 2, 2022
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT03126136
Brief Title
Pulse Pressure Variability With Position Before EPIdural Analgesia
Acronym
PP-PERI
Official Title
Predictive Value of a Postural Test on Pulse Pressure Variation During Labor With Epidural Analgesia on Fetal Heart Rate Abnormalities
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor, Epidural Analgesia
Keywords
Fetal heart rate abnormalities, Pregnancy, Epidural analgesia, Pulse pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregnant women
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Nicom (TM)
Intervention Description
Heart rate, arterial pressure and cardiac output measurements (monitor NICOM) performed in the dorsal decubitus position and in the left lateral decubitus
Primary Outcome Measure Information:
Title
Fetal heart rate
Description
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.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Fetal heart rate
Description
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
Time Frame
4 days
Title
Mode of delivery
Description
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.
Time Frame
4 days
Title
Newborn heart rate, blood pressure, pulse pressure, and cardiac output
Description
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.
Time Frame
4 days
Title
Number of patients with hemodynamic abnormalities
Description
Heart rate, blood pressure, pulse pressure, and cardiac output measured before and after epidural analgesia.
Time Frame
4 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morgan Le Guen, MD
Organizational Affiliation
Hôpital Foch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Fischler, MD PhD
Organizational Affiliation
Hôpital Foch
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Frédéric Mercier, MD PhD
Organizational Affiliation
AP-HP Hôpital A. Béclère
Official's Role
Study Chair
Facility Information:
Facility Name
AP-HP Hopital Antoine Beclere
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Institut Hospitalier Franco-Britannique
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23769849
Citation
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.
Results Reference
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Pulse Pressure Variability With Position Before EPIdural Analgesia

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