Epidural Analgesia, Labor
Conditions
Keywords
Fetal heart rate abnormalities, Pregnancy, Epidural analgesia, Pulse pressure
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.
Interventions
DEVICENicom (TM)
Heart rate, arterial pressure and cardiac output measurements (monitor NICOM) performed in the dorsal decubitus position and in the left lateral decubitus
Sponsors
Hopital Foch
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| Number of patients with hemodynamic abnormalities | 4 days | Heart rate, blood pressure, pulse pressure, and cardiac output measured before and after epidural analgesia. |
Countries
France
Outcome results
None listed