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Could a special gauze replace stitches for Post-Birth tears?

NCT ID NCT06998641

Disease control Sponsor: Istanbul Training and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests whether a special gauze coated with chitosan, a natural substance that helps blood clot, can stop bleeding from minor tears after childbirth as effectively as traditional stitches. Women with first- or second-degree postpartum lacerations will be randomly assigned to receive either the gauze or suturing. Researchers will compare bleeding amount, comfort, hospital stay, and complications to see if the gauze offers a gentler option.

What this could mean

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

Active substance
Chitosan-covered gauze applied to bleeding obstetric lacerations
What this could lead to
If effective, this could offer a less invasive alternative to suturing for postpartum tears, potentially reducing pain and recovery time.
What could go wrong
This is a small, early-stage trial, and the gauze may not control bleeding as well as sutures in all cases, or it could increase infection risk.

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

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 48 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: * Women who delivered at the Department of Obstetrics and Gynecology of Istanbul Training and Research Hospital between March 2025 and March 2027. * Age between 18 and 48 years. * Presence of a bleeding postpartum obstetric laceration (first- or second-degree) without an anatomical defect requiring surgical repair. * Absence of additional conditions that may affect the amount of postpartum bleeding, such as uterine atony or retained placental tissue. * Provision of written informed consent for participation in the study. Exclusion Criteria: * Age younger than 18 years or older than 48 years. * Absence of a bleeding postpartum first- or second-degree obstetric laceration meeting the study criteria. * Presence of an obstetric laceration with an anatomical defect requiring surgical repair. * Presence of additional causes or conditions that may affect postpartum blood loss, such as uterine atony or retained placental tissue. * Failure to provide informed consent.

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As listed by the trial registrant

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

Comparison of the effect of chitosan covered gauze with suturing in terms of hemostasis in post-partum haemorrhagic tears Effectiveness of chitosan covered gauze to stop bleeding in post-partum tears

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Istanbul Training and Research Hospital Department of Obstetrics and Gynecology

    RECRUITING

    Istanbul, Turkey (Türkiye)