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OpenTrials
Completed

NCT Number: NCT02962830

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.

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Key information

Conditions

Prenatal Diagnosis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Jeanne de Flandres, CHRU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sufentanil

Drug

intra-amniotic injection of 10 micrograms of Sufentanil

Primary outcomes

  1. 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

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: 2IAS

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Nov 11, 2016
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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