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Gel vs ointment: which helps new mothers heal faster after episiotomy?

NCT ID NCT07814781

Symptom relief Sponsor: Hamad Medical Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers compare two topical treatments for healing episiotomy wounds after childbirth: a hydrophilic methacrylate gel and a beta-sitosterol ointment. The trial enrolls 107 first-time mothers who had a mediolateral episiotomy during vaginal delivery. Trained observers blinded to the treatment assess wound healing using the REEDA scale, which tracks redness, swelling, bruising, discharge, and how well the wound edges come together. Women also report pain, cosmetic appearance, satisfaction, and ease of use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydrophilic methacrylate gel and beta-sitosterol ointment
What this could lead to
If one treatment helps wounds heal faster or with less pain, it could become a standard option for women recovering from episiotomy after childbirth.
What could go wrong
This is a small, single-center study of first-time mothers with a specific type of cut. The results may not apply to other women or delivery situations, and neither treatment is guaranteed to outperform the other or usual care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

107 people

The number who actually took part.

Started

Dec 2023

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Episiotomy Perineal wound healing

Contacts and locations

Locations

  • Al Wakra Hospital

    Doha, 3050, Qatar

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