Chitosan-covered gauze versus sutures to stop bleeding from postpartum first- and second-degree tears
Official title: EFFECTIVITY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS
Run by Istanbul Training and Research Hospital · NCT06998641 · Data updated 2026-11-12
This trial will test whether a chitosan-covered gauze tampon can stop bleeding as well as traditional suturing in women with first- or second-degree postpartum lacerations.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 48 Years |
| Sex | Women only |
| Enrollment | 62 (estimated) |
| Sponsor | Istanbul Training and Research Hospital Government |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | March 2027 |
| Study ends | December 2027 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT06998641 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18–48 who deliver at Istanbul Training and Research Hospital between March 2025 and March 2027 and have first- or second-degree postpartum lacerations without other causes of bleeding.
✕Probably not a fit
Patients who require anatomical defect repair or who have additional bleeding causes such as uterine atony or retained placenta are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Women who give birth at the Istanbul Training and Research Hospital and experience first- or second-degree obstetric lacerations with postpartum bleeding will be randomly assigned to either chitosan-covered gauze application with compression or standard suturing. Participants will be monitored during the immediate postpartum hospitalization and followed at the routine six-week postpartum visit to document bleeding control and healing. The trial excludes patients who need anatomical defect repair or who have other causes of increased bleeding such as uterine atony or retained placenta. Outcomes will focus on hemostasis, need for additional interventions, and routine postpartum recovery metrics.
Why it matters
Potential benefit: If successful, the chitosan-covered gauze could provide a faster, less invasive way to stop bleeding from minor postpartum tears and reduce the need for sutures.
How similar studies have gone: Hemostatic chitosan dressings have shown promising results in trauma and surgical settings, but their use for postpartum perineal tears is limited and relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Istanbul Training and Research Hospital Department of Obstetrics and Gynecology
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Doruk C Katlan
- Email: dcek2000@yahoo.com
- Phone: +90 535 347 54 11
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.