Chitosan-covered gauze versus sutures to stop bleeding from postpartum first- and second-degree tears
EFFECTİVİTY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 48 Years |
| Sex | Female |
| Sponsor | Istanbul Training and Research Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06998641 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Hemostatic chitosan dressings have shown promising results in trauma and surgical settings, but their use for postpartum perineal tears is limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients, 18-48 years old, who gave birth in Istanbul TRH between March 2025 and March 2027 experiencing 1st and 2nd degree obstetric lacerations with postpartum hemorrhage without the need for anatomical defect repairing and without additional conditions such as uterine atony, placental rest, etc. that may affect the amount of postpartum bleeding. Exclusion Criteria: Patients not fullfilling the inclusion criteria in terms of age limits, time and place of birth or ones who are experiencing 1st and 2nd degree obstetric lacerations with postpartum hemorrhage with the need for anatomical defect repairing and with additional conditions such as uterine atony, placental rest, etc. that may affect the amount of postpartum bleeding.
Where this trial is running
Istanbul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.