CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 228 enrolled
Drug / intervention
Preservative-free epidural morphine +1 moredrug
Likely dose
Preservative-free epidural morphine 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00803114
NCT00803114Phase 4Completed
CompareCT.gov

Epidural Morphine Following Vaginal Delivery: A Randomised, Double-Blind, Placebo-Controlled Trial

Mount Sinai Hospital, Canada·interventional·Posted Dec 5, 2008·Updated Jan 14, 2009

In Brief

A Phase 4 clinical trial evaluating Preservative-free epidural morphine and Placebo for Pain. Completed, enrolled 228 participants across 1 site.

Detailed Summary

The investigators believe that pain management following a vaginal delivery can be improved. Many women receive epidural medication during labor and delivery, and the investigators felt that using the epidural following delivery might improve the first day pain. This study is to determine whether a single dose of epidural morphine given to mothers after a vaginal delivery will reduce the perineal pain in the postpartum period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesCanada
CollaboratorsThe Physicians' Services Incorporated Foundation

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2008
Enrollment StartMar 1, 2002
Primary CompletionNov 1, 2004
Study CompletionFeb 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.6 years ago

Interventions

Preservative-free epidural morphinedrug

One time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery

Placebodrug

5 ml of epidural preservative-free saline given within one hour following vaginal delivery