Rectal Versus Oral Diclofenac Sodium in Relieving Post Ep... | NCT04331210

Studies
Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

NCT04331210

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Apr 2, 2020Actual

Enrollment

1,024Estimated

Phase

Not Applicable

Conditions

Episiotomy Wound

Interventions

Diclofenac Sodium

Countries

Not provided

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

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Estimated

Primary Completion Date

Sep 1, 2021Estimated

Completion Date

Oct 1, 2021Estimated

First Submitted Date

Mar 27, 2020

First Submission Date that Met QC Criteria

Mar 31, 2020

First Posted Date

Apr 2, 2020Actual

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

Mar 31, 2020

Last Update Posted Date

Apr 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Current study aims to compare oral diclofenac sodium with it's rectal form for analgesia of pain after episiotomy.

Detailed Description

Episiotomy is a surgical incision of the perineum and the posterior vaginal wall.
it can be done at a 60 degree angle from the vulva towards the anus or at an angle from the posterior end of the vulva.
usually under local anesthetic and is sutured after delivery.
It is done during second stage of labor to enlarge the opening for the baby to pass through to avoid soft-tissue tearing which may involve the anal sphincter and rectum.
Perineal pain after episiotomy has immediate and long-term negative effects for women and their babies. These effects can interfere with breastfeeding and the care of the infant.
Usually women undergo episiotomy need a good analgesic to overcome pain resulting from the analgesic.
Previous study by Faiza shafi, Shazia sayed, Naheed bano, Rizwana chaudhri, Holy family hospital, Rawalpindi, Pakistan, The study was published in journal of Rawalpindi medical college and concluded that rectal diclofenac should be further promoted , for pain relief, in women following episiotomy.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,024Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Active Comparator	Using diclofenac sodium suppository 50 mg immediately after suturing and then every 8 hours	Drug: Diclofenac Sodium
Group 2	Active Comparator	Using diclofenac sodium tablets 50 mg every 8 hours after birth	Drug: Diclofenac Sodium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diclofenac Sodium	Drug	Group 1 will take oral diclofenac sodium and group 2 will take Rectal diclofenac sodium as an analgesic	Group 1 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post episiotomy pain relief	The relief of pain after delivery measured by pain relief scale..Pain relief scale Title: pain intensity scale Minimum 0 means no pain Maximum 4 means severe pain	First three days after delivery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age: 20:35 years.
Primigravidae as elective procedure.
face to pubis delivery.
Big baby.
Narrow pelvic arch.
Elderly primigravida.
old perineal scar as episiotomy or perineorrhaphy.
Manipulative delivery.
To cut short second stage cases such as pre eclampsia.
Premature baby.
Fetal distress.

Exclusion Criteria:

more than 35 years.
pelvic inflammatory disease.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammed Hosny, Physician	Contact	01140762577		Elto3my@yahoo.com

Overall Officials

Name	Affiliation	Role
Diaa eldin Mohammed, Professor	women health hospital assiut university	Study Chair
Osama Saber, Lecturer	women health hospital assiut university	Study Director

Locations

Not provided

References Module

Citations

Not provided

Label	URL
Worldwide website written collaporatively by people who use it	View source
a free search engine accessing primarily the MEDLINE database of references and abstracts on life sciences and biomedical topics	View source

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals