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

August 2, 2022 updated by: Hopital Foch

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fetal heart rate
Time Frame: 4 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fetal heart rate
Time Frame: 4 days
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
Time Frame: 4 days
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
Time Frame: 4 days
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
Time Frame: 4 days
Heart rate, blood pressure, pulse pressure, and cardiac output measured before and after epidural analgesia.
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hopital Foch

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Marc Fischler, MD PhD, Hôpital Foch
  • Study Chair: Frédéric Mercier, MD PhD, AP-HP Hôpital A. Béclère

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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