Sufentanil Pharmacokinetics After Intra Amniotic Injection

Phase 2

• Conditions: Prenatal Diagnosis
• Interventions: Drug: Sufentanil

• Registration Number: NCT02962830
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-11
• Study Start: 2017-04-19
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-13
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sufentanil	Sufentanil	-

Primary Outcome Measures

Name	Time	Method
fetal plasma concentrations	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 Outcome Measures

Name	Time	Method
amniotic fluid concentrations	Immediately within 5 min after intra-amniotic injection	The amniotic fluid concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector)
Maternal plasma concentrations	at 30 minutes and at 1, 2, 4, 8, 24 hours after intra-amniotic injection	Maternal plasma concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector)

Trial Locations

Locations (1)

Hôpital Jeanne de Flandres, CHRU; 🇫🇷 Lille, France