NCT02962830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

April 19, 2017

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2024

Completed
Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

7.1 years

First QC Date

August 17, 2016

Last Update Submit

December 2, 2025

Conditions

Prenatal Diagnosis

Keywords

fetal painfetal analgesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Maternal plasma concentrations

    at 30 minutes and at 1, 2, 4, 8, 24 hours after intra-amniotic injection

  • amniotic fluid concentrations

    Immediately within 5 min after intra-amniotic injection

Study Arms (1)

Sufentanil

EXPERIMENTAL
Drug: Sufentanil

Interventions

SufentanilDRUG

intra-amniotic injection of 10 micrograms of Sufentanil

Sufentanil

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Termination of pregnancy for fetal malformation
  • Gestational age \> 24 weeks of gestation

You may not qualify if:

  • Multiple pregnancy
  • Allergy or contraindication to sufentanil
  • Morphinic addiction
  • fetal gastroschisis, omphalocele or swallowing disorder
  • maternal cardiac or respiratory distress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Jeanne de Flandres, CHRU

Lille, France

Location

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Véronique HOUFFLIN-DEBARGE, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

November 11, 2016

Study Start

April 19, 2017

Primary Completion

May 28, 2024

Study Completion

May 29, 2024

Last Updated

December 3, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)