Pulse Pressure Variability With Position Before EPIdural Analgesia

Not Applicable

Completed

• Conditions: Labor; Epidural Analgesia
• Interventions: Device: Nicom (TM)

• Registration Number: NCT03126136
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Study Start: 2018-12-12
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnant women	Nicom (TM)	-

Primary Outcome Measures

Name	Time	Method
Fetal heart rate	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

Name	Time	Method
Newborn heart rate, blood pressure, pulse pressure, and cardiac output	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.
Mode of delivery	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.
Number of patients with hemodynamic abnormalities	4 days	Heart rate, blood pressure, pulse pressure, and cardiac output measured before and after epidural analgesia.
Fetal heart rate	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

Trial Locations

Locations (4)

AP-HP Hopital Antoine Beclere; 🇫🇷 Clamart, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Hopital Foch; 🇫🇷 Suresnes, France

Institut Hospitalier Franco-Britannique; 🇫🇷 Levallois-Perret, France