SUFENTANIL intra–amniotic injection

SUFENTANIL maternal and foetal pharmacokinetic evaluation after intra–amniotic injection

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001721-16-FR

Enrollment

Registered

2015-07-27

Start date

2015-07-24

Completion date

Unknown

Last updated

2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 18.0 Level: HLGT Classification code 10053098 Term: Foetal and neonatal investigations System Organ Class: 10022891 - Investigations

Interventions

Trade Name: SUFENTANIL Product Name: SUFENTANIL Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women aged 18 and over Member of French social security scheme Single pregnancy Hospitalized subject for medical termination of pregnancy Gestational age equal to or greater than 24 weeks of amenorrhea Inform consent form signature Are the trial subjects under 18? yes Number of subjects for this age range: 35 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Women under age 18 (minor) Under tutorship or guardianship Selective medical terminiation during multiple pregnancy Foetal deformation which can interfere on the foetal absorption of SUFENTANIL (gastrochisis, omphalocele...), fetal swallowing disorder (thyroid goiter, cervical mass ...) Emergency procedures Allergic maternal history known about the SUFENTANIL or morphine Contraindications in the anesthesia epidural which can give appeal to the use of morphines substances for medical termination of pregnancy Medical necessity of a maternal treatment considered by the anaesthetist as being able to interfere with the injection of SUFENTANIL Addicted to morphine Morphine long-term treatment Maternal cardiac or respiratory pathology against indicating a treatment by SUFENTANIL Refusal of the patient to participate in the study after information

Design outcomes

Primary

Measure	Time frame
Main Objective: We shall try to estimate the fotal plasma absorption of the SUFENTANIL after an intra-amniotic injection during the procedures of medical interruption of pregnancy with fœticide. We wish to know if this method of administration allows to obtain therapeutic fetal concentrations of morphine.;Secondary Objective: Know if the SUFENTANIL administered by intra-amniotic route allows to obtain therapeutic serum levels without maternal and fetal adverse event;Primary end point(s): Morphine derivatives fetal plasma concentrations;Timepoint(s) of evaluation of this end point: Sampling of blood for the SUFENTANIL fetal plasma level 30 minutes after the injection (Intraumbilical)	—

Measure

Time frame

Main Objective: We shall try to estimate the fotal plasma absorption of the SUFENTANIL after an intra-amniotic injection during the procedures of medical interruption of pregnancy with fœticide. We wish to know if this method of administration allows to obtain therapeutic fetal concentrations of morphine.;Secondary Objective: Know if the SUFENTANIL administered by intra-amniotic route allows to obtain therapeutic serum levels without maternal and fetal adverse event;Primary end point(s): Morphine derivatives fetal plasma concentrations;Timepoint(s) of evaluation of this end point: Sampling of blood for the SUFENTANIL fetal plasma level 30 minutes after the injection (Intraumbilical)

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Secondary

Measure	Time frame
Secondary end point(s): Morphine derivatives maternal plasma concentrations Morphine derivatives amniotic fluid concentrations Maternal and fetal Adverse events / serious adverses events;Timepoint(s) of evaluation of this end point: - Sampling of blood for the SUFENTANIL maternal plasma level (catheter): • 30 minutes after the injection • 60 minutes after the injection • 120 minutes after the injection • 24 hours after the injection - Sampling of amniotic fluid for the SUFENTANIL level: • When the needle is removed - Maternal and fetal Adverse events / serious adverses events data captures	—

Measure

Time frame

Secondary end point(s): Morphine derivatives maternal plasma concentrations Morphine derivatives amniotic fluid concentrations Maternal and fetal Adverse events / serious adverses events;Timepoint(s) of evaluation of this end point: - Sampling of blood for the SUFENTANIL maternal plasma level (catheter): • 30 minutes after the injection • 60 minutes after the injection • 120 minutes after the injection • 24 hours after the injection - Sampling of amniotic fluid for the SUFENTANIL level: • When the needle is removed - Maternal and fetal Adverse events / serious adverses events data captures

—

Countries

France

Contacts

Public ContactClinical Research Associate

Centre Hospitalier Régional et Universitaire de Lille

edouard.millois@chru-lille.fr33320444145

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026