The Randomised Epidural Analgesia in Term Delivering Women Trial (TREAT)

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Male

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 multicentre randomised open label trial.

• Study population: Term nulliparous and multiparous women with a child in cephalic presentation, and without contraindications for vaginal labour or EA.

• Intervention: Women will be allocated to the EA group or the care-as-usual group. In the EA group, women are given an EA as soon as they are in labour. In the care-as-usual (restrictive) group, women receive pain relief only on their explicit request.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Maastricht University Medical Center
• Treatments: Dsuvia; Ropivacaine; Sufentanil

Criteria

Inclusion Criteria:

• 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 Criteria:

• be younger than 18 years

• bear twin pregnancy

• have contraindications for vaginal labour

• have contraindications for EA

• referral by midwife during labour (first line)