A Phase 3 interventional study of Dexamethasone and Placebo in Obstetric Pain and Other Complications of Obstetric Anesthesia - Delivered, sponsored by Centre Hospitalier Universitaire de la Réunion. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by Centre Hospitalier Universitaire de la Réunion · Phase 3, Interventional, and Treatment
To assess the efficacy of epidural dexamethasone administration, compared to placebo, in reducing local anesthetics consumption during labor epidural analgesia in parturient women
It is hypothesized that reducing the consumption of local anesthetics during labor epidural analgesia could lower their side effects (rate of motor block, nausea and emesis during labor, maternal hypotension, maternal fever) and improve the duration of the second part of the labor, and the new-born adaptation to child-birth and during the first 24 hours. The use of instruments for assisted vaginal delivery and the needs to perform emergency cesarean could also be impacted.
The efficacy of the dexamethasone will be assessed by the hourly Ropivacaine consumption (milligrams/hour) measured from randomization time to the end of epidural analgesia.
395 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
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Exclusion Criteria:
Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil)
Drug: Dexamethasone · Drug: Ropivacaine · Drug: Sufentanil
Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil)
Drug: Placebo · Drug: Ropivacaine · Drug: Sufentanil
single epidural injection of dexamethasone (8 mg) in addition to local anesthetics used for epidural analgesia
Also known as: Dexamethasone MYLAN
single epidural injection of sodium chloride 0.9% (2 mL) in addition to local anesthetics used for epidural analgesia
Also known as: Sodium chloride LAVOISIER 0.9 %
NAROPEINE 7.5 mg/mL is diluted at the concentration of 1 mg/mL prior to the epidural use. The perfused dose depends on the efficacy of analgesia in reducing the delivery labor pain.
Also known as: NAROPEINE 7.5 mg/ml, anhydrous ropivacaine chlorhydrate
Sufentanil 0.5 mg/L is used as solution for injection for epidural analgesia and used in combination with ropivacaine. The administered dose is bolus of 15 to 20 micrograms diluted into 10 mL.
Also known as: Sufentanil Mylan 0.5 microg/mL
Hourly ropivacaine consumption expressed as mg/mL used during epidural analgesia in parturient women
The administered dose of ropivacaine during epidural is used to measure the efficacy of Dexamethasone in reducing local anesthetics during labor analgesia
Time frame: From the beginning to the end of epidural analgesia, that could last up to 6 hours
Improvement of epidural analgesia assessed by the reduction of adverse effects induced by local anesthetics
Adverse effects such as nausea and emesis, maternal hypotension, maternal hyperthermia will be recorded during epidural analgesia
Time frame: From the beginning to the end of epidural analgesia, that could last up to 6 hours
Dexamethasone effect maternal pain during delivery assessed by Visual Analogic Scale
Evaluation of the lowered maternal pain induced by Dexamethasone
Time frame: From the beginning to the end of epidural analgesia, that could last up to 6 hours
Improvement of delivery assessed by recording the number of side events (motor block, emergency cesarean, instrument-assisted delivery)
Rates of motor block, emergency cesarean, instrument-assisted delivery
Time frame: From the beginning to the end of epidural analgesia, that could last up to 6 hours
Maternal satisfaction assessed by visual analogic scale
Patient satisfaction visual analogic scale
Time frame: On the morning of the next day after delivery, up to 24 hours
New-born adaptation to child-birth assessed by "Apgar score"
Apgar score assessed twice: at 1 minute and 5 minutes after child-birth
Time frame: up to 5 minutes after child-birth
New-born adaptation to child-birth assessed by umbilical biochemical parameters
Measurement of umbilical pH and lactates values at child-birth
Time frame: umbilical blood collection up to 5 minutes after child-birth
New-born adaptation to child-birth assessed by the rate of neonatal respiratory distress
Rate of neonatal respiratory distress during the first 24 hours after child-birth
Time frame: 0-24 hours after child-birth
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de la Réunion