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NCT Number: NCT06998641

EFFECTİVİTY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS

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.

Recruiting

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Key information

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Amount of bleeding

    Time frame: From time of birth to the cessation of bleeding

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

Study contacts

Contact information is provided by the study sponsor or research team.

Doruk C Katlan

CONTACT

[email protected]

+90 535 347 54 11

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.