Sufentanil Pharmacokinetics After Intra Amniotic Injection
NCT ID: NCT02962830
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
8 participants
INTERVENTIONAL
2017-04-19
2024-05-29
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sufentanil
Sufentanil
intra-amniotic injection of 10 micrograms of Sufentanil
Interventions
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Sufentanil
intra-amniotic injection of 10 micrograms of Sufentanil
Eligibility Criteria
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Inclusion Criteria
* Gestational age \> 24 weeks of gestation
Exclusion Criteria
* Allergy or contraindication to sufentanil
* Morphinic addiction
* fetal gastroschisis, omphalocele or swallowing disorder
* maternal cardiac or respiratory distress
18 Years
FEMALE
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Véronique HOUFFLIN-DEBARGE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hôpital Jeanne de Flandres, CHRU
Lille, , France
Countries
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Other Identifiers
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2015-001721-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2014_19
Identifier Type: -
Identifier Source: org_study_id
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