Sufentanil Pharmacokinetics After Intra Amniotic Injection

Prenatal Diagnosis Clinical Trial

— 2IAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02962830
• Other study ID #: 2014_19
• Secondary ID: 2015-001721-16
• Status: Recruiting
• Phase: Phase 2
• Start date: April 19, 2017
• Est. completion date: October 2022

Study information

• Verified date: May 2020
• Source: University Hospital, Lille
• Contact: Véronique HOUFFLIN-DEBARGE, MD,PhD
• Phone: +33-3 20 44 69 08
• Email: veronique.debarge[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prenatal Diagnosis

Intervention

Drug:
• Sufentanil
intra-amniotic injection of 10 micrograms of Sufentanil

Locations

Country	Name	City	State
France	Hôpital Jeanne de Flandres, CHRU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	amniotic fluid concentrations	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