Pulse Pressure Variability With Position Before EPIdural Analgesia

Labor Clinical Trial

— PP-PERI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126136
• Other study ID #: 2016/31
• Secondary ID: 2016- A00846-45
• Status: Completed
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epidural Analgesia
• Labor

Intervention

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

Locations

Country	Name	City	State
France	AP-HP Hopital Antoine Beclere	Clamart
France	Institut Hospitalier Franco-Britannique	Levallois-Perret
France	Institut Mutualiste Montsouris	Paris
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of patients with hemodynamic abnormalities	Heart rate, blood pressure, pulse pressure, and cardiac output measured before and after epidural analgesia.	4 days