EFFECTİVİTY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS

Istanbul Training and Research Hospital

Status: Enrolling

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

Treatments: Procedure: Suturation; Procedure: Chitosan-covered-gauze application

Study type: Interventional

Funder types: Other

Identifiers

NCT06998641

ISTANBUL TRH - 21.03.2025 - 65

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

chitosan-covered-gauze applied tears

Experimental group

Description:

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

Treatment:

Procedure: Chitosan-covered-gauze application

Suturation group

Active Comparator group

Description:

Hemostasis of the tears is obtained by suturing

Treatment:

Procedure: Suturation