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

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ClinicalTrials.gov Identifier: NCT03126136
Recruitment Status : Not yet recruiting
First Posted : April 24, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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.

Condition or disease Intervention/treatment Phase
Labor Epidural Analgesia Device: Nicom (TM) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictive Value of a Postural Test on Pulse Pressure Variation During Labor With Epidural Analgesia on Fetal Heart Rate Abnormalities
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pregnant women
  • gestational age > 37 weeks
  • single eutrophic fetus
  • wishing for epidural analgesia
  • cervical dilatation less than or equal to 5 cm
  • spontaneous labor
  • scheduled for a vaginal delivery.

Exclusion Criteria:

  • prematurity or post-term birth
  • induction of labour using oxytocin 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
  • hematocrit less than 20%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126136


Contacts
Contact: Morgan Le Guen, MD +33(0)146252998 m.leguen@hopital-foch.org

Locations
France
AP-HP Hopital Antoine Beclere Not yet recruiting
Clamart, France, 92140
Contact: Frederic Mercier, MD PhD    +33(0)145374444    frederic.mercier@abc.aphp.fr   
Principal Investigator: Frederic Mercier, MD PhD         
Institut Hospitalier Franco-Britannique Not yet recruiting
Levallois-Perret, France, 92300
Contact: Agnes Bonnet, MD    +33(0)146392261    agnes.bonnet@ihfb.org   
Principal Investigator: Agnes Bonnet, MD         
Institut Mutualiste Montsouris
Paris, France, 75014
Hopital Foch Not yet recruiting
Suresnes, France, 92150
Contact: Morgan Le Guen, MD    +33(0)146252998    m.leguen@hopital-foch.org   
Principal Investigator: Morgan Le Guen, MD         
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Morgan Le Guen, MD Hôpital Foch
Study Chair: Marc Fischler, MD PhD Hôpital Foch
Study Chair: Frédéric Mercier, MD PhD AP-HP Hôpital A. Béclère

Publications:
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03126136     History of Changes
Other Study ID Numbers: 2016/31
2016- A00846-45 ( Other Identifier: ANSM )
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hopital Foch:
Fetal heart rate abnormalities
Pregnancy
Epidural analgesia
Pulse pressure

Additional relevant MeSH terms:
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms