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New gel combo may speed healing after birth tear repair

NCT ID NCT07545187

Symptom relief Sponsor: Alaa Nadhim Hameed 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding diltiazem gel to standard fusidic acid cream helps heal episiotomy wounds faster and reduces pain after vaginal delivery. 100 first-time mothers applied either the combo or cream alone twice daily for 10 days. Researchers checked healing and pain on days 3, 7, and 10.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

100 people

The number who actually took part.

Started

Jun 2025

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 40 years

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: * Primiparous women * Singleton term pregnancy. * Vaginal delivery with mediolateral episiotomy. * Willingness to participate and provide informed consent. Exclusion Criteria: * Known hypersensitivity to diltiazem or fusidic acid. * Pre-existing local perineal infection. * Chronic systemic disease likely to impair wound healing, including uncontrolled diabetes or immunosuppressive conditions.

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As listed by the trial registrant

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

Episiotomy infection Episiotomy wound Episiotomy wound healing Normal vaginal delivery Surgical site infection of episiotomy Surgical site infection prevention

Contacts and locations

Locations

  • University of Kirkuk, Medical Collage

    Kirkuk, Kirkuk Governorate, 36001, Iraq

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