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NCT Number: NCT07814781

Optimizing Early Episiotomy Wound Healing

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Al Wakra Hospital

Doha, 3050, Qatar

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Primigravida (first pregnancy)
  • Live term singleton pregnancy
  • Underwent mediolateral episiotomy without tear during vaginal delivery
  • Adequate reading and writing literacy

Exclusion criteria

  • 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

Treatment and study plan

Beta-Sitosterol Ointment

Drug

Topical ointment containing beta-sitosterol applied to the episiotomy/perineal wound site

Hydrophilic Methacrylate Gel

Drug

Hydrophilic methacrylate-based hydrogel applied to the episiotomy/perineal wound site

Primary outcomes

  1. 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.

Secondary outcomes

  1. Complete Wound Healing (REEDA = 0) Assessed at Day 12

    Time frame: Day 12 postpartum

    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.

  2. Patient-Reported Pain

    Time frame: Day 12 postpartum

    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.

  3. Patient Satisfaction (Patient-Reported Outcome)

    Time frame: Day 12 postpartum

    Patient-reported overall satisfaction with treatment (categorized as satisfied/very satisfied vs not satisfied).

  4. Treatment Effectiveness Perception (Patient-Reported Outcome)

    Time frame: Day 12 postpartum

    Patient-reported perceived effectiveness of treatment (categorized as effective/very effective vs not effective).

  5. Perineal Cosmetic Appearance (Patient-Reported Outcome)

    Time frame: Day 12 postpartum

    Patient-reported cosmetic appearance of the perineal wound (categorized as improved somewhat/significantly vs no change or worsened).

  6. Ease of Application (Patient-Reported Outcome)

    Time frame: Day 12 postpartum

    Ease of applying the topical treatment, categorized as easy/very easy vs neutral or difficult.

  7. Likelihood of Treatment Recommendation (Patient-Reported Outcome)

    Time frame: Day 12 postpartum

    Likelihood of recommending the treatment to others (categorized as likely/definitely recommend vs neutral or unlikely).

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

Optimizing Early Episiotomy Wound Healing: A Randomized Controlled Trial of Hydrophilic Methacrylate Gel Versus Beta-Sitosterol Ointment

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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