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French Agency for the Safety of Health Products refusal
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural analgesia + DEXAMETHASONE | Experimental | Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil) |
|
| Epidural analgesia + PLACEBO | Placebo Comparator | Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | single epidural injection of dexamethasone (8 mg) in addition to local anesthetics used for epidural analgesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the beginning to the end of epidural analgesia, that could last up to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the beginning to the end of epidural analgesia, that could last up to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| New-born adaptation to child-birth assessed by "Apgar score" | Apgar score assessed twice: at 1 minute and 5 minutes after child-birth | up to 5 minutes after child-birth |
| New-born adaptation to child-birth assessed by umbilical biochemical parameters |
Inclusion Criteria:
Exclusion Criteria:
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|
| Placebo | Drug | single epidural injection of sodium chloride 0.9% (2 mL) in addition to local anesthetics used for epidural analgesia |
|
|
| Ropivacaine | Drug | 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. |
|
|
| Sufentanil | Drug | 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. |
|
|
| Dexamethasone effect maternal pain during delivery assessed by Visual Analogic Scale |
Evaluation of the lowered maternal pain induced by Dexamethasone |
| 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 | 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 | On the morning of the next day after delivery, up to 24 hours |
Measurement of umbilical pH and lactates values at child-birth
| 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 | 0-24 hours after child-birth |
| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000077212 | Ropivacaine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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