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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001721-16 | EudraCT Number |
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The fetus may be exposed during pregnancy to nociceptive stimuli because of fetal pathology (e.g., malformation) or a diagnostic or therapeutic procedure.
To date, there is very little data and no consensus on fetal analgesia. The aim of the investigators study is to evaluate the pharmacokinetics of Sufentanil after intra amniotic injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufentanil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil | Drug | intra-amniotic injection of 10 micrograms of Sufentanil |
|
| Measure | Description | Time Frame |
|---|---|---|
| fetal plasma concentrations | fetal plasma concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector) | at 30 minutes after intra-amniotic injection |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal plasma concentrations | Maternal plasma concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector) | at 30 minutes and at 1, 2, 4, 8, 24 hours after intra-amniotic injection |
| amniotic fluid concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Véronique HOUFFLIN-DEBARGE, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Jeanne de Flandres, CHRU | Lille | France |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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The amniotic fluid concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector) |
| Immediately within 5 min after intra-amniotic injection |