Effect of Intravenous Dexamethasone Before Spinal Anesthe... | NCT03122756

Studies
Effect of Intravenous Dexamethasone Before Spinal Anesthesia on Post-cesarean Section Pain

NCT03122756

Sponsor

Ain Shams Maternity Hospital

Status

Unknown status

Last Update Posted

Aug 14, 2018Actual

Enrollment

100Estimated

Phase

Early Phase 1

Conditions

Cesarean Section

Interventions

Dexamethasone
Normal Saline

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Oct 2018Estimated

Completion Date

Oct 2018Estimated

First Submitted Date

Apr 12, 2017

First Submission Date that Met QC Criteria

Apr 18, 2017

First Posted Date

Apr 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2018

Last Update Posted Date

Aug 14, 2018Actual

Name	Class
Ain Shams University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

*Research Hypothesis: In women undergoing cesarean section, intravenous injection of dexamethasone prior to spinal anesthesia may reduce post-cesarean section pain.

*Research Question: In women undergoing cesarean section, does injecting intravenous dexamethasone prior to spinal anesthesia reduce post-cesarean section pain?

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	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.	Group (D)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
sensory recovery	sensory recovery time by cold object	2, 4, 8 and 12 hours after the procedure
motor recovery	motor recovery time on Bromage scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women who will be planned for elective cesarean section.

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud AA ElShourbagy, MD	Contact	+201001448189		elshourbagym22@hotmail.com

Overall Officials

Name	Affiliation	Role
Mahmoud AA ElShourbagy, MD	Professor of Obstetrics and Gynecology	Study Chair
Dalia A Nasr, MD	Professor of Anesthesia, Intensive Care and Pain	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams Maternity Hospital	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D002123	Calcium Dobesilate
D000077330	Saline Solution

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

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Browse Branches

Not provided