Randomised, placebo controlled clinical trial to evaluate remifentanil as maternal sedation and fetal immobilisation during diagnostic prenatal MRI.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011281-28-BE

Enrollment

Registered

2009-03-19

Start date

2009-04-17

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal sedation and fetal immobilization during MRI

Interventions

Trade Name: Ultiva Pharmaceutical Form: Intravenous infusion INN or Proposed INN: REMIFENTANIL HYDROCHLORIDE CAS Number: 132539072 Concentration unit: mg milligram(s) Concentration type: equal Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Gestational age between 18 and 34 weeks no contra indication for MRI no allergy for remifentanil Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Evaluation of fetal immobilization during prenatal MRI 2. Evaluation of maternal sedation during prenatal MRI;Secondary Objective: ;Primary end point(s):	—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026