EpisiotomyNCT07814781
Optimizing Early Episiotomy Wound Healing
A study testing Beta-Sitosterol Ointment and Hydrophilic Methacrylate Gel in people with Episiotomy and Perineal Wound Healing, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
This randomized controlled trial compares hydrophilic methacrylate gel versus beta-sitosterol ointment for early episiotomy wound healing. A total of 107 women who underwent mediolateral episiotomy during vaginal delivery were allocated to receive either hydrophilic methacrylate gel (n=53) or beta-sitosterol ointment… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Episiotomy, Perineal Wound Healing
- What is being tested?
- Beta-Sitosterol Ointment and Hydrophilic Methacrylate Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteQatar
- Study dates
- 15 Dec 2023to 1 Nov 2024
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Primigravida (first pregnancy)
- Live term singleton pregnancy
- Underwent mediolateral episiotomy without tear during vaginal delivery
- Adequate reading and writing literacy
Who cannot join
- Known dermatological conditions affecting wound healing
- Hypersensitivity to study products
- Systemic inflammatory disease
- Chronic systemic disease that delays wound healing (e.g., coagulation disorders, diabetes, anemia with Hb <9 g/dl)
- Prior perineal injury, surgery, or visible lesions (e.g., genital warts, hemorrhoids)
- Inability to attend follow-up appointments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Early Episiotomy Wound Healing: A Randomized Controlled Trial of Hydrophilic Methacrylate Gel Versus Beta-Sitosterol Ointment
This randomized controlled trial compares hydrophilic methacrylate gel versus beta-sitosterol ointment for early episiotomy wound healing. A total of 107 women who underwent mediolateral episiotomy during vaginal delivery were allocated to receive either hydrophilic methacrylate gel (n=53) or beta-sitosterol ointment (n=54). Wound outcomes were assessed by trained observers blinded to treatment allocation and by patients at two time points approximately 12 days apart. The primary outcome was the REEDA score (Redness, Edema, Ecchymosis, Discharge, Approximation). Secondary outcomes included patient-reported pain, cosmetic appearance, satisfaction, perceived treatment effectiveness, ease of application, and likelihood of recommending treatment.
Read the detailed description
Wound healing following episiotomy is a complex biological process influenced by mechanical stress, inflammatory response, tissue perfusion, and patient-related factors. This prospective randomized single-blinded controlled trial enrolled adult women who underwent mediolateral episiotomy during vaginal delivery at a tertiary care maternity hospital in Qatar. Exclusion criteria included known dermatological conditions affecting wound healing, hypersensitivity to study products, systemic inflammatory disease, chronic conditions delaying healing (e.g., coagulation disorders, diabetes, anemia with Hb <9 g/dl), prior perineal injury, surgery, or visible lesions, or inability to attend follow-up. A total of 107 women were allocated to receive either hydrophilic methacrylate gel (n=53) or beta-sitosterol ointment (n=54).Outcome assessments were performed by trained observers blinded to treatment allocation and by patients at two time points approximately 12 days apart. Observer-assessed outcomes used the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation). Patient-reported outcomes included pain, cosmetic appearance, overall satisfaction, perceived treatment effectiveness, ease of application, and likelihood of recommending treatment.
- Conditions
- Episiotomy, Perineal Wound Healing
- Being tested
- Beta-Sitosterol Ointment, Hydrophilic Methacrylate Gel
- Keywords
- Episiotomy, Wound Healing, Hydrophilic Methacrylate Gel, Beta-Sitosterol Ointment, REEDA Scale, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-Sitosterol OintmentDrug
Topical ointment containing beta-sitosterol applied to the episiotomy/perineal wound site
Hydrophilic Methacrylate GelDrug
Hydrophilic methacrylate-based hydrogel applied to the episiotomy/perineal wound site
| Study group | Role | What they receive |
|---|---|---|
| Beta-Sitosterol Ointment | Active comparator | Participants applied Beta-Sitosterol ointment to the episiotomy/perineal wound site twice daily (morning and evening) for 2 weeks. Receives: Drug: Beta-Sitosterol Ointment |
| Hydrophilic Methacrylate Gel | Experimental | Participants applied Hydrophilic methacrylate gel to the episiotomy/perineal wound site twice daily (morning and evening) for 2 weeks. Receives: Drug: Hydrophilic Methacrylate Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perineal Wound Healing Assessed by REEDA Scale
Measured using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation) total score, where higher scores indicate worse wound healing, assessed by trained observers blinded to treatment allocation.
Measured: Assessed at two time points: Day 5 postpartum and Day 12 postpartum
Secondary outcomes (7)
Complete Wound Healing (REEDA = 0) Assessed at Day 12
Proportion of participants with a REEDA total score of 0 (no observed redness, edema, ecchymosis, discharge, or approximation abnormality) at Day 12 postpartum, assessed by trained observers blinded to treatment allocation.
Measured: Day 12 postpartum
Patient-Reported Pain
Patient-reported pain rated on a 5-category verbal scale (None/Mild/Moderate/Severe/Very severe), categorized as none or mild vs. moderate to very severe.
Measured: Day 12 postpartum
Patient Satisfaction (Patient-Reported Outcome)
Patient-reported overall satisfaction with treatment (categorized as satisfied/very satisfied vs not satisfied).
Measured: Day 12 postpartum
Treatment Effectiveness Perception (Patient-Reported Outcome)
Patient-reported perceived effectiveness of treatment (categorized as effective/very effective vs not effective).
Measured: Day 12 postpartum
Perineal Cosmetic Appearance (Patient-Reported Outcome)
Patient-reported cosmetic appearance of the perineal wound (categorized as improved somewhat/significantly vs no change or worsened).
Measured: Day 12 postpartum
Ease of Application (Patient-Reported Outcome)
Ease of applying the topical treatment, categorized as easy/very easy vs neutral or difficult.
Measured: Day 12 postpartum
Likelihood of Treatment Recommendation (Patient-Reported Outcome)
Likelihood of recommending the treatment to others (categorized as likely/definitely recommend vs neutral or unlikely).
Measured: Day 12 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start15 Dec 2023
- Primary completion8 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Yehia El Khawly, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814781
- Sponsor's protocol ID
- 01-23-518-EPIS
- Other IDs
- MRC-01-23-518
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. De-identified data may be made available to external collaborators under a separate institutional data use agreement for specific academic purposes, but IPD is not being made available for public sharing.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Early Episiotomy Wound Healing: A Randomized Controlled Trial of Hydrophilic Methacrylate Gel Versus Beta-Sitosterol Ointment
- ClinicalTrials.gov ID
- NCT07814781
- Acronym / sponsor ID
- 01-23-518-EPIS
- Conditions
- Episiotomy, Perineal Wound Healing
- Keywords
- Episiotomy, Wound Healing, Hydrophilic Methacrylate Gel, Beta-Sitosterol Ointment, REEDA Scale, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 11 Sep 2026 (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.
This randomized controlled trial compares hydrophilic methacrylate gel versus beta-sitosterol ointment for early episiotomy wound healing. A total of 107 women who underwent mediolateral episiotomy during vaginal delivery were allocated to receive either hydrophilic methacrylate gel (n=53) or beta-sitosterol ointment (n=54). Wound outcomes were assessed by trained observers blinded to treatment allocation and by patients at two time points approximately 12 days apart. The primary outcome was the REEDA score (Redness, Edema, Ecchymosis, Discharge, Approximation). Secondary outcomes included patient-reported pain, cosmetic appearance, satisfaction, perceived treatment effectiveness, ease of application, and likelihood of recommending treatment.
Detailed description
Wound healing following episiotomy is a complex biological process influenced by mechanical stress, inflammatory response, tissue perfusion, and patient-related factors. This prospective randomized single-blinded controlled trial enrolled adult women who underwent mediolateral episiotomy during vaginal delivery at a tertiary care maternity hospital in Qatar. Exclusion criteria included known dermatological conditions affecting wound healing, hypersensitivity to study products, systemic inflammatory disease, chronic conditions delaying healing (e.g., coagulation disorders, diabetes, anemia with Hb <9 g/dl), prior perineal injury, surgery, or visible lesions, or inability to attend follow-up. A total of 107 women were allocated to receive either hydrophilic methacrylate gel (n=53) or beta-sitosterol ointment (n=54).Outcome assessments were performed by trained observers blinded to treatment allocation and by patients at two time points approximately 12 days apart. Observer-assessed outcomes used the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation). Patient-reported outcomes included pain, cosmetic appearance, overall satisfaction, perceived treatment effectiveness, ease of application, and likelihood of recommending treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-Sitosterol Ointment | Active comparator | Drug: Beta-Sitosterol OintmentParticipants applied Beta-Sitosterol ointment to the episiotomy/perineal wound site twice daily (morning and evening) for 2 weeks. |
| Hydrophilic Methacrylate Gel | Experimental | Drug: Hydrophilic Methacrylate GelParticipants applied Hydrophilic methacrylate gel to the episiotomy/perineal wound site twice daily (morning and evening) for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Primigravida (first pregnancy)
- Live term singleton pregnancy
- Underwent mediolateral episiotomy without tear during vaginal delivery
- Adequate reading and writing literacy
Key exclusion criteria (6 listed)
- Known dermatological conditions affecting wound healing
- Hypersensitivity to study products
- Systemic inflammatory disease
- Chronic systemic disease that delays wound healing (e.g., coagulation disorders, diabetes, anemia with Hb <9 g/dl)
- Prior perineal injury, surgery, or visible lesions (e.g., genital warts, hemorrhoids)
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 |
|---|---|---|
| Beta-Sitosterol OintmentTopical ointment containing beta-sitosterol applied to the episiotomy/perineal wound site | Drug | Beta-Sitosterol Ointment |
| Hydrophilic Methacrylate GelHydrophilic methacrylate-based hydrogel applied to the episiotomy/perineal wound site | Drug | Hydrophilic Methacrylate Gel |
Primary outcome
Perineal Wound Healing Assessed by REEDA Scale
Time frame: Assessed at two time points: Day 5 postpartum and Day 12 postpartum
Measured using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation) total score, where higher scores indicate worse wound healing, assessed by trained observers blinded to treatment allocation.
7 secondary outcomes
Complete Wound Healing (REEDA = 0) Assessed at Day 12
Time frame: Day 12 postpartum
Patient-Reported Pain
Time frame: Day 12 postpartum
Patient Satisfaction (Patient-Reported Outcome)
Time frame: Day 12 postpartum
Treatment Effectiveness Perception (Patient-Reported Outcome)
Time frame: Day 12 postpartum
Perineal Cosmetic Appearance (Patient-Reported Outcome)
Time frame: Day 12 postpartum
Ease of Application (Patient-Reported Outcome)
Time frame: Day 12 postpartum
Likelihood of Treatment Recommendation (Patient-Reported Outcome)
Time frame: Day 12 postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. De-identified data may be made available to external collaborators under a separate institutional data use agreement for specific academic purposes, but IPD is not being made available for public sharing.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-Sitosterol Ointment and Hydrophilic Methacrylate Gel in people with Episiotomy and Perineal Wound Healing, run by Hamad Medical Corporation at 1 site in Qatar.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perineal Wound Healing Assessed by REEDA Scale (time frame: Assessed at two time points: Day 5 postpartum and Day 12 postpartum). 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 11 Sep 2026.