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

NCT01261689 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2013-11-27

No results posted yet for this study

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.

Conditions

  • Analgesia, Epidural
  • Instrumental Delivery
  • Maternal Outcome
  • Neonatal Outcome

Interventions

DRUG

Ropivacaine/ Sufentanil according to local hospital protocol

according to local hospital protocol

OTHER

Care-as usual pain treatment

Pain treatment only on request of the women in labour. Treatment is given according to local hospital protocol.

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Jan Nijhuis, Prof. MD, PhD · Maastricht University Medical Center

  • Martine Wassen, MD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01261689 on ClinicalTrials.gov