NCT02588417

Brief Summary

To evaluate the effectiveness of adding dexamethasone to intrathecal levobupivacaine in combined spinal epidural (CSE) analgesia during vaginal delivery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_2

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

July 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

October 26, 2015

Last Update Submit

October 27, 2015

Conditions

Effects of; Anesthesia, in Labor and Delivery

Outcome Measures

Primary Outcomes (1)

  • duration of spinal analgesia

    1 day

Secondary Outcomes (1)

  • time from spinal analgesia to delivery

    1 day

Study Arms (2)

dexamethasone

ACTIVE COMPARATOR

dexamethasone 4 mg administered intrathecally during active stage of labor once only in combination with levobupivacaine

Drug: DexamethasoneDrug: Levobupivacaine

levobupivacaine

ACTIVE COMPARATOR

levobupivacaine 2.5 mg in 2 ml administered intrathecally during active stage of labor once and alone and then epidural levobupivacaine 7ml of 2.5 mg concentrationis administered till the end of labor

Drug: Levobupivacaine

Interventions

DexamethasoneDRUG

4mg dexamethasone intrathecally plus levobupivacaine 2.5 mg

Also known as: decadron
dexamethasone
LevobupivacaineDRUG

levobupivacaine 2.5 mg

Also known as: chirocaine
dexamethasonelevobupivacaine

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status I,II patients schedueled for normal vaginal deliveries
  • age between 18-35 years old

You may not qualify if:

  • Patients who refused to participate
  • complicated pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

DexamethasoneCalcium DobesilateLevobupivacaine

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsBupivacaineAnilidesAmidesAniline CompoundsAmines

Study Officials

  • nadia yo helmy, md

    professor of anaesthesia cairo university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 27, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

October 28, 2015

Record last verified: 2015-10