EFFECTİVİTY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS

NCT06998641 | Recruiting DMC

• 1 other identifier: ISTANBUL TRH - 21.03.2025 - 65
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Effectiveness of Chitosan Covered Gauze to Stop Bleeding in Post-partum Tears; Comparison of the Effect of Chitosan Covered Gauze With Suturing in Terms of Hemostasis in Post-partum Haemorrhagic Tears

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Amount of bleeding

  Total amount of blood which is calculated by subtracting the dry weight of surgical absorbant gauze materials from their soaked weight

  From time of birth to the cessation of bleeding

Study Arms (2)

chitosan-covered-gauze applied tears

EXPERIMENTAL

Hemostasis of the tears is obtained by the application of chitosan-covered-gauze

Procedure: Chitosan-covered-gauze application

Suturation group

ACTIVE COMPARATOR

Hemostasis of the tears is obtained by suturing

Procedure: Suturation

Interventions

Chitosan-covered-gauze application PROCEDURE

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

chitosan-covered-gauze applied tears

Suturation PROCEDURE

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

Suturation group

Eligibility Criteria

• Age: 18 Years - 48 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital Department of Obstetrics and Gynecology

Istanbul, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Doruk C Katlan

CONTACT

+90 535 347 54 11; dcek2000@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medicine Specialist

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

TU (1)