Clinical trial NCT03126136: Pulse Pressure Variability With Position Before EPIdural Analgesia
Official title: Predictive Value of a Postural Test on Pulse Pressure Variation During Labor With Epidural Analgesia on Fetal Heart Rate Abnormalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor
Epidural Analgesia
Keywords: Fetal heart rate abnormalities
Pregnancy
Epidural analgesia
Pulse pressure
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fetal heart rate
timeFrame: 4 days
Secondary outcomes:
measure: Fetal heart rate
timeFrame: 4 days
measure: Mode of delivery
timeFrame: 4 days
measure: Newborn heart rate, blood pressure, pulse pressure, and cardiac output
timeFrame: 4 days
measure: Number of patients with hemodynamic abnormalities
timeFrame: 4 days
Other outcomes:
Locations:
city: Clamart
country: France
facility: AP-HP Hopital Antoine Beclere
city: Levallois-Perret
country: France
facility: Institut Hospitalier Franco-Britannique
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hôpital Foch
name: Morgan Le Guen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Foch
name: Marc Fischler, MD PhD
role: STUDY_CHAIR
affiliation: AP-HP Hôpital A. Béclère
name: Frédéric Mercier, MD PhD
role: STUDY_CHAIR
References:
citation: 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.