Sufentanil Pharmacokinetics After Intra Amniotic Injection (2IAS)

University Hospital, Lille

Status and phase: Unknown; Phase 2

Conditions: Prenatal Diagnosis

Treatments: Drug: Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02962830

2014_19

2015-001721-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Sufentanil

Experimental group

Treatment:

Drug: Sufentanil