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Recruiting NCT06998641

EFFECTİVİTY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS

No phase Interventional 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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chitosan-covered-gauze application, Suturation.
Who it may be relevant to
Registry 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. Basic parameters: 18 years — 48 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Procedure 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
  • 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

Primary outcome measures

  • Amount of bleeding [Time frame: From time of birth to the cessation of bleeding]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Training and Research Hospital Department of Obstetrics and Gynecology — Istanbul

Identifiers

NCT: NCT06998641 · ISTANBUL TRH - 21.03.2025 - 65

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗