Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

NCT ID: NCT04331210

Last Updated: 2020-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1024 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-10-01

Brief Summary

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

Detailed Description

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* 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.

Conditions

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Episiotomy Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

Using diclofenac sodium suppository 50 mg immediately after suturing and then every 8 hours

Group Type ACTIVE_COMPARATOR

Diclofenac Sodium

Intervention Type DRUG

Group 1 will take oral diclofenac sodium and group 2 will take Rectal diclofenac sodium as an analgesic

Group 2

Using diclofenac sodium tablets 50 mg every 8 hours after birth

Group Type ACTIVE_COMPARATOR

Diclofenac Sodium

Intervention Type DRUG

Group 1 will take oral diclofenac sodium and group 2 will take Rectal diclofenac sodium as an analgesic

Interventions

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Diclofenac Sodium

Group 1 will take oral diclofenac sodium and group 2 will take Rectal diclofenac sodium as an analgesic

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. age: 20:35 years.
2. Primigravidae as elective procedure.
3. face to pubis delivery.
4. Big baby.
5. Narrow pelvic arch.
6. Elderly primigravida.
7. old perineal scar as episiotomy or perineorrhaphy.
8. Manipulative delivery.
9. To cut short second stage cases such as pre eclampsia.
10. Premature baby.
11. Fetal distress.

Exclusion Criteria

1. more than 35 years.
2. pelvic inflammatory disease.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Hosny Ahmed

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diaa eldin Mohammed, Professor

Role: STUDY_CHAIR

women health hospital assiut university

Osama Saber, Lecturer

Role: STUDY_DIRECTOR

women health hospital assiut university

Central Contacts

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Mohammed Hosny, Physician

Role: CONTACT

01140762577

Related Links

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https://en.m.wikipedia.org/wiki/Episiotomy

Worldwide website written collaporatively by people who use it

https://pubmed.ncbi.nlm.nih.gov/17465071

a free search engine accessing primarily the MEDLINE database of references and abstracts on life sciences and biomedical topics

Other Identifiers

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Post episiotomy analgesia

Identifier Type: -

Identifier Source: org_study_id

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