Sufentanil Pharmacokinetics After Intra Amniotic Injection (2IAS)

May 11, 2020 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lille, France
        • Recruiting
        • Hôpital Jeanne de Flandres, CHRU
        • Principal Investigator:
          • Véronique Houfflin-Debarge, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sufentanil
Drug: Sufentanil
intra-amniotic injection of 10 micrograms of Sufentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at 30 minutes after intra-amniotic injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal plasma concentrations
Time Frame: 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)
at 30 minutes and at 1, 2, 4, 8, 24 hours after intra-amniotic injection
amniotic fluid concentrations
Time Frame: 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)
Immediately within 5 min after intra-amniotic injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2017

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Actual)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 11, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014_19
  • 2015-001721-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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