A Phase 2 interventional study of Sufentanil in Prenatal Diagnosis, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by University Hospital, Lille · Phase 2, Interventional, and Treatment
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.
University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Sufentanil
intra-amniotic injection of 10 micrograms of Sufentanil
fetal plasma concentrations
fetal plasma concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector)
Time frame: at 30 minutes after intra-amniotic injection
Maternal plasma concentrations
Maternal plasma concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector)
Time frame: at 30 minutes and at 1, 2, 4, 8, 24 hours after intra-amniotic injection
amniotic fluid concentrations
The amniotic fluid concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector)
Time frame: Immediately within 5 min after intra-amniotic injection
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille