Pregnant women who want to receive analgesia during labour MedDRA version: 9.1 Level: SOC Classification code 10036585
Conditions
Interventions
Trade Name: FENTATIENIL
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sufentanil
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 50
Sponsors
AZIENDA OSPEDALIERA ISTITUTI CLINICI DI PERFEZIONAMENTO DI MILANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Nulliparous women, at the end of pregnancy, active labour. 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: Women with any problem during pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TO VALUE IF AND HOW MANY CHANGES IN THE CARDIOTOCOGRAPHIC TRACE ARE DURING CSE IN LABOUR USING DIFFERENT DOSES OF SPINAL OPIATE;Secondary Objective: CORRELATION BETWEEN CHANGES IN CARDIOTOCOGRAPHIC TRACE AND MATERNAL BLOOD PRESSURE AND QUALITY OF ANALGESYA;Primary end point(s): TO VALUE IF AND HOW MANY CHANGES IN THE CARDIOTOCOGRAPHIC TRACE ARE DURING CSE IN LABOUR USING DIFFERENT DOSES OF SPINAL OPIATE | — |
Countries
Italy
Outcome results
None listed