Status:
COMPLETED
The Randomised Epidural Analgesia in Term Delivering Women Trial (TREAT)
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Analgesia, Epidural
Instrumental Delivery
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
\* The objective of the study: to assess the impact of a proactive policy of offering EA at the start of labour as compared to a restrictive policy or care as usual. \* Study design: It concerns a mu...
Detailed Description
Labour pain can be regarded as one of the most serious kinds of pain.In many countries labour pain is effectively treated on request of the labouring woman. In The Netherlands, labour pain has been tr...
Eligibility Criteria
Inclusion
- be 18 years or older
- bear a singleton child in cephalic presentation
- be under supervision (second line) for their pregnancy in one of the participating centres.
- have no contraindications for vaginal labour
- have no contraindications for EA: Use of coumarines LMWH in therapeutic dose LMWH in prophylactic dose, less than 10 hours ago Thrombocytes \< 80 x 109/ L Use of thrombocytes aggregation inhibitors or anamnestic increased bleeding tendency Blood clotting disorders Allergy for used anesthetics Spine disorders or back infection
Exclusion
- be younger than 18 years
- bear twin pregnancy
- have contraindications for vaginal labour
- have contraindications for EA
- referral by midwife during labour (first line)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT01261689
Start Date
September 1 2008
End Date
November 1 2013
Last Update
November 27 2013
Active Locations (2)
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1
Atrium Medical Centre Parkstad
Heerlen, Limburg, Netherlands, 6419 PC
2
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6202 AZ