Assessment of Fetal and Maternal Sufentanil Pharmacokinetics After Intra-amniotic Injection

University Hospital, Lille1 site in 1 country8 target enrollmentApril 19, 2017

ConditionsPrenatal Diagnosis

InterventionsSufentanil

DrugsSufentanil

Overview

Phase: Phase 2
Intervention: Sufentanil
Conditions: Prenatal Diagnosis
Sponsor: University Hospital, Lille
Enrollment: 8
Locations: 1
Primary Endpoint: fetal plasma concentrations
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 19, 2017

End Date

May 29, 2024

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University Hospital, Lille

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Sufentanil

Intervention: Sufentanil

Outcomes

Primary Outcomes

fetal plasma concentrations

Time Frame: at 30 minutes after intra-amniotic injection

fetal plasma concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector)

Secondary Outcomes

amniotic fluid concentrations(Immediately within 5 min after intra-amniotic injection)
Maternal plasma concentrations(at 30 minutes and at 1, 2, 4, 8, 24 hours after intra-amniotic injection)