Prenatal DiagnosisPhase 22IASNCT02962830
Sufentanil Pharmacokinetics After Intra Amniotic Injection
A Phase 2 study testing Sufentanil in people with Prenatal Diagnosis, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prenatal Diagnosis
- What is being tested?
- Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2017to 29 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Termination of pregnancy for fetal malformation
- Gestational age > 24 weeks of gestation
Who cannot join
- Multiple pregnancy
- Allergy or contraindication to sufentanil
- Morphinic addiction
- fetal gastroschisis, omphalocele or swallowing disorder
- maternal cardiac or respiratory distress
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prenatal Diagnosis
- Being tested
- Sufentanil
- Keywords
- fetal pain, fetal analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
intra-amniotic injection of 10 micrograms of Sufentanil
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil | Experimental | Not described Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal plasma concentrations
fetal plasma concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector)
Measured: at 30 minutes after intra-amniotic injection
Secondary outcomes (2)
Maternal plasma concentrations
Maternal plasma concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector)
Measured: at 30 minutes and at 1, 2, 4, 8, 24 hours after intra-amniotic injection
amniotic fluid concentrations
The amniotic fluid concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector)
Measured: Immediately within 5 min after intra-amniotic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start19 Apr 2017
- Primary completion28 May 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal DiagnosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique HOUFFLIN-DEBARGE, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962830
- Sponsor's protocol ID
- 2014_19
- Other IDs
- 2015-001721-16, 2015
- Acronym
- 2IAS
- Status last verified
- Dec 2025
- First submitted
- 17 Aug 2016
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fetal and Maternal Sufentanil Pharmacokinetics After Intra-amniotic Injection
- ClinicalTrials.gov ID
- NCT02962830
- Acronym / sponsor ID
- 2IAS / 2014_19
- Conditions
- Prenatal Diagnosis
- Keywords
- fetal pain, fetal analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sufentanil | Experimental | Drug: Sufentanil |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Termination of pregnancy for fetal malformation
- Gestational age > 24 weeks of gestation
Key exclusion criteria (5 listed)
- Multiple pregnancy
- Allergy or contraindication to sufentanil
- Morphinic addiction
- fetal gastroschisis, omphalocele or swallowing disorder
- maternal cardiac or respiratory distress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sufentanilintra-amniotic injection of 10 micrograms of Sufentanil | Drug | Sufentanil |
Primary outcome
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)
2 secondary outcomes
Maternal plasma concentrations
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Véronique HOUFFLIN-DEBARGE, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sufentanil in people with Prenatal Diagnosis, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fetal plasma concentrations (time frame: at 30 minutes after intra-amniotic injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.