NCT02665936

Brief Summary

The purpose of this study is to detect whether the addition of epidural dexamethasone will prolong labor analgesia.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_2

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

January 13, 2016

Last Update Submit

January 27, 2016

Conditions

Labor

Keywords

epidural analgesia

Outcome Measures

Primary Outcomes (1)

  • Duration of epidural analgesia

    an average of 5 months

Secondary Outcomes (1)

  • Time of onset of sensory block at level T10

    an average of 5 months

Study Arms (3)

group L

ACTIVE COMPARATOR

Epidural levobupivacaine 0.125% (Chirocaine) in normal saline in a total volume of 10 ml will be administered epidurally in active stage of labor

Drug: Levobupivacaine

group LD4

ACTIVE COMPARATOR

Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 4 mg in a total volume 10 ml

Drug: Dexamethasone and levobupivacaine

group LD8

ACTIVE COMPARATOR

Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 8 mg in a total volume 10 ml

Drug: Levobupivacaine and Dexamethasone

Interventions

LevobupivacaineDRUG

Levobupivacaine will be given epidurally and the duration of analgesia will be calculated

group L
Dexamethasone and levobupivacaineDRUG

dexamethasone 4 mg epidurally with levobupivacaine and duration of analgesia is measured

group LD4
Levobupivacaine and DexamethasoneDRUG

dexamethasone 8 mg epidurally with levobupivacaine and duration of analgesia is measured

group LD8

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status I, II
  • normal vaginal delivery In early active phase of labor
  • singleton cephalic presentation at term

You may not qualify if:

  • complicated pregnancies
  • morbid obesity
  • diagnosed fetal abnormalities
  • contra-indications to regional anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

LevobupivacaineDexamethasone

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • ahmed i elsakka, m,d,

    Cairo University

    PRINCIPAL INVESTIGATOR

  • amira r hassan, m,d.

    Cairo University

    STUDY CHAIR

  • nadia y helmy, m.d.

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
m.d. anasthesia

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 28, 2016

Study Start

October 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

January 28, 2016

Record last verified: 2016-01