Effect on mother and fetus of epidural and combined spinal-epidural techniques for labour analgesia - CSE
- Conditions
- abour
- Registration Number
- EUCTR2009-017665-31-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Well established labour
Maternal request of analgesia
Cervical dilatation ≤ 5 cm in nulliparous or ≤ 3 cm in multiparous patients
Vertex presentation
Written informed consensus
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
ASA > II
Twin pregnancy
Congenital or acquired coagulation diseases (plts ≤ 70000/mmc, INR > 1,2, clinical evidence)
Use of anticoagulant or antiplatelet agents
Infection over the injection site
Marked hypovolemia
Nonreassuring fetal heart rate abnormalities
Unintentional dural puncture
Failing finding epidural space
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: : to compare the effects of epidural analgesia and combined spinal/epidural analgesia on uteroplacental circulation, maternal hemadynamics and the length of the first and second stage of labour;Secondary Objective: to evaluate the synergic role of opioid (sufentanil) and local anaesthetic (l-bupivacaine) and thus the minimal effective epidural local anaesthetic volume;Primary end point(s): less use of oxytocin and cut down of the length of the first stage of labour using combined spinal-epidural analgesia
- Secondary Outcome Measures
Name Time Method