EFFECTİVİTY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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chitosan-covered-gauze applied tears

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

Group Type EXPERIMENTAL

Chitosan-covered-gauze application

Intervention Type 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

Suturation group

Hemostasis of the tears is obtained by suturing

Group Type ACTIVE_COMPARATOR

Suturation

Intervention Type 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

Interventions

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Chitosan-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

Intervention Type PROCEDURE

Suturation

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No