NCT03122756

Brief Summary

\*Aim of the Work This study aims to assess the efficacy of intravenous injection of dexamethasone prior to spinal anesthesia in reducing post-cesarean section pain in women undergoing cesarean section.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 12, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

April 12, 2017

Last Update Submit

August 13, 2018

Conditions

Cesarean Section

Keywords

Intravenous DexamethasoneSpinal AnesthesiaPost-cesarean Section Pain

Outcome Measures

Primary Outcomes (1)

  • change in post-cesarean pain

    post-cesarean pain degree scored by the patient on Visual Analogue Scale

    2, 4, 8 and 12 hours after the procedure

Secondary Outcomes (5)

  • sensory recovery

    2, 4, 8 and 12 hours after the procedure

  • motor recovery

    2, 4, 8 and 12 hours after the procedure

  • nausea

    2, 4, 8 and 12 hours after the procedure

  • vomiting

    2, 4, 8 and 12 hours after the procedure

  • shivering

    2, 4, 8 and 12 hours after the procedure

Study Arms (2)

Group (D)

EXPERIMENTAL

will include 50 women who will receive intravenous dexamethasone.

Drug: Dexamethasone

Group (C)

PLACEBO COMPARATOR

will include 50 women who will receive intravenous normal saline (0.9 %).

Other: Normal Saline

Interventions

DexamethasoneDRUG

Intravenous injection of dexamethasone 0.1 mg/kg maximum 8 mg (diluted with distilled water to 2 mL) just prior to administration of spinal anesthesia.

Also known as: Decadron
Group (D)
Normal SalineOTHER

Intravenous injection 2 mL intravenous normal saline (0.9 %) just prior to administration of spinal anesthesia.

Group (C)

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women who will be planned for elective cesarean section.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A gestational age of 38 weeks or more and planned for elective cesarean section.
  • Living fetus.
  • Any number of previous cesarean section.
  • Intact amniotic membranes.
  • No history of bleeding tendency.

You may not qualify if:

  • Refuse to participate after counseling.
  • Contraindication to spinal anesthesia (coagulopathy significant hypovolemia systemic or local sepsis - increased intracranial pressure - local anesthetic or fentanyl allergy).
  • High risk pregnancies as pre-eclampsia, any medical disorder (diabetes mellitus, cardiac disease or and thyroid disease).
  • Contraindication to corticosteroids e.g. systemic fungal infection
  • Steroid medication one week before the operation.
  • Chronic pain or daily intake of analgesic.
  • Abnormal placentation e.g. placenta previa.
  • Intrauterine infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

DexamethasoneCalcium DobesilateSaline Solution

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Mahmoud AA ElShourbagy, MD

    Professor of Obstetrics and Gynecology

    STUDY CHAIR

  • Dalia A Nasr, MD

    Professor of Anesthesia, Intensive Care and Pain

    STUDY DIRECTOR

  • Bassem A Islam, MD

    Lecturer in Obstetrics & Gynecology

    STUDY DIRECTOR

  • Abdelhameed AA Ismail, MBBCh

    Resident of Obstetrics & Gynecology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud AA ElShourbagy, MD

CONTACT

+201001448189elshourbagym22@hotmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 21, 2017

Study Start

August 1, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)