Episiotomy WoundNCT04331210
Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain
A study testing Diclofenac Sodium in people with Episiotomy Wound, run by Assiut University.
Trial summary
Current study aims to compare oral diclofenac sodium with it's rectal form for analgesia of pain after episiotomy. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy Wound
- What is being tested?
- Diclofenac Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,024 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 20:35 years.
- Primigravidae as elective procedure.
- face to pubis delivery.
- Big baby.
- Narrow pelvic arch.
- Elderly primigravida.
Show all 11Show fewer
- old perineal scar as episiotomy or perineorrhaphy.
- Manipulative delivery.
- To cut short second stage cases such as pre eclampsia.
- Premature baby.
- Fetal distress.
Who cannot join
- more than 35 years.
- pelvic inflammatory disease.
Trial locations and contacts
No sites are listed yet.
About this study
Current study aims to compare oral diclofenac sodium with it's rectal form for analgesia of pain after episiotomy.
Read the 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.
- Conditions
- Episiotomy Wound
- Being tested
- Diclofenac Sodium
- Keywords
- Episiotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac SodiumDrug
Group 1 will take oral diclofenac sodium and group 2 will take Rectal diclofenac sodium as an analgesic
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Using diclofenac sodium suppository 50 mg immediately after suturing and then every 8 hours Receives: Drug: Diclofenac Sodium |
| Group 2 | Active comparator | Using diclofenac sodium tablets 50 mg every 8 hours after birth Receives: Drug: Diclofenac Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First three days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy WoundStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,024 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hosny Ahmed, Assiut University
- Investigators
- Diaa eldin Mohammed, Professor, Study chair, women health hospital assiut universityOsama Saber, Lecturer, Study director, women health hospital assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331210
- Sponsor's protocol ID
- Post episiotomy analgesia
- Status last verified
- Mar 2020
- First submitted
- 27 Mar 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Iidentify individual participant data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain
- ClinicalTrials.gov ID
- NCT04331210
- Acronym / sponsor ID
- Post episiotomy analgesia
- Conditions
- Episiotomy Wound
- Keywords
- Episiotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,024 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Diclofenac SodiumUsing diclofenac sodium suppository 50 mg immediately after suturing and then every 8 hours |
| Group 2 | Active comparator | Drug: Diclofenac SodiumUsing diclofenac sodium tablets 50 mg every 8 hours after birth |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- age: 20:35 years.
- Primigravidae as elective procedure.
- face to pubis delivery.
- Big baby.
- Narrow pelvic arch.
Key exclusion criteria (2 listed)
- more than 35 years.
- pelvic inflammatory disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac SodiumGroup 1 will take oral diclofenac sodium and group 2 will take Rectal diclofenac sodium as an analgesic | Drug | Group 1, Group 2 |
Primary outcome
Post episiotomy pain relief
Time frame: First three days after delivery
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Worldwide website written collaporatively by people who use itLink provided by the sponsor.
- a free search engine accessing primarily the MEDLINE database of references and abstracts on life sciences and biomedical topicsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Iidentify individual participant data for all primary and secondary outcome measures will be made available
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RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diaa eldin Mohammed, Professor study chair
women health hospital assiut university
Osama Saber, Lecturer study director
women health hospital assiut university
Questions about this trial
What is this clinical trial studying?
A study testing Diclofenac Sodium in people with Episiotomy Wound, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Hosny, Physician (01140762577, Elto3my@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post episiotomy pain relief (time frame: First three days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.