CompletedPhase 2

Sufentanil Pharmacokinetics After Intra Amniotic Injection

France8 participantsStarted 2017-04-19

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Termination of pregnancy for fetal malformation * Gestational age \> 24 weeks of gestation Exclusion Criteria: * Multiple pregnancy * Allergy or contraindication to sufentanil * Morphinic addiction * fetal gastroschisis, omphalocele or swallowing disorder * maternal cardiac or respiratory distress

What they're measuring

fetal plasma concentrations

Timeframe: at 30 minutes after intra-amniotic injection

Trial details

NCT IDNCT02962830

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-28

View on ClinicalTrials.gov More Prenatal Diagnosis trials