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EFFECTIVITY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS

EFFECTIVITY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06998641
Enrollment
62
Registered
2025-05-31
Start date
2025-03-01
Completion date
2027-12-01
Last updated
2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

chitosan-covered-gauze, post-partum lacerations, obstetrical tears

Brief summary

This study was planned to investigate the efficacy of different treatment methods that can be used in the treatment of hemorrhagic tears that may occur in the postpartum period. The volunteers who will participate in the study will be evaluated during the hospitalization period after delivery and at the end of the puerperium 6 weeks after delivery, in accordance with routine postpartum control examinations. In the treatment of postpartum hemorrhagic tears, the treatment options such as suturing the tears to stop bleeding or applying tampons with bleeding stopping agent (chitosan) and compression effect to the torn area will be determined completely randomly.

Interventions

PROCEDUREChitosan-covered-gauze application

Effectiveness of chitosan-covered-gauze in terms of patients' comfort and satisfaction, hospital stay, total amount of bleeding, hemoglobin decline and other complications (infections, need for transfusion etc.) for the treatment of hemorrhagic obstetrical tears

PROCEDURESuturation

Effectiveness of suturation in terms of patients' comfort and satisfaction, hospital stay, total amount of bleeding, hemoglobin decline and other complications (infections, need for transfusion etc.) for the treatment of hemorrhagic obstetrical tears

Sponsors

Istanbul Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Amount of bleedingFrom time of birth to the cessation of bleedingTotal amount of blood which is calculated by subtracting the dry weight of surgical absorbant gauze materials from their soaked weight

Countries

Turkey (Türkiye)

Contacts

CONTACTDoruk C Katlan
dcek2000@yahoo.com+90 535 347 54 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026