NCT02313571

Brief Summary

The computer-integrated patient controlled epidural analgesia (CIPCEA) system can automatically adjust the background infusion rate during combined spinal-epidural (CSE) analgesia based on the parturient's need as labour progresses. Analysis of parturients experiencing breakthrough pain may identify associated factors that can also be related to obstetric or foetal outcomes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

5.3 years

First QC Date

December 7, 2014

Last Update Submit

September 3, 2015

Conditions

Pain

Keywords

Epidural AnalgesiaPain

Outcome Measures

Primary Outcomes (1)

  • Breakthrough Pain (Requiring unscheduled epidural supplementation by anaesthetists)

    Requiring unscheduled epidural supplementation by anaesthetists

    1 day

Secondary Outcomes (2)

  • Caesarean Section (Rate of caesarean section)

    1 day

  • Instrumental Delivery (Rate of instrumental delivery)

    1 day

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women who had nulliparous requested for labour epidural analgesia

You may qualify if:

  • Nulliparous women,
  • requested for epidural analgesia

You may not qualify if:

  • Multiparous women,
  • unable to perform combined spinal epidural technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ban L Sng, FANZCA

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2014

First Posted

December 10, 2014

Study Start

March 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 4, 2015

Record last verified: 2015-09

Locations

SG(1)