Pulse Pressure Variability With Position Before EPIdural Analgesia

Study Overview
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Brief Summary
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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.

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

Conditions
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Labor, Epidural Analgesia

Intervention / Treatment
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* Device: Nicom (TM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal heart rate abnormalities, Pregnancy, Epidural analgesia, Pulse pressure