EFFECTIVITY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS

ConditionsEffectiveness 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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-48

SponsorIstanbul Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women who delivered at the Department of Obstetrics and Gynecology of Istanbul Training and Research Hospital between March 2025 and March 2027.

Age between 18 and 48 years.

Presence of a bleeding postpartum obstetric laceration (first- or second-degree) without an anatomical defect requiring surgical repair.

Absence of additional conditions that may affect the amount of postpartum bleeding, such as uterine atony or retained placental tissue.

Disqualifiers

Age younger than 18 years or older than 48 years.

Absence of a bleeding postpartum first- or second-degree obstetric laceration meeting the study criteria.

Presence of an obstetric laceration with an anatomical defect requiring surgical repair.

Presence of additional causes or conditions that may affect postpartum blood loss, such as uterine atony or retained placental tissue.

Trial design

Design model

Parallel

Treatments tested in this trial

Chitosan-covered-gauze application
Procedure/Surgery
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/Surgery
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

Treatment groups

62 Participants

are divided into 2 treatment groups

Group A: chitosan-covered-gauze applied tearsExperimental treatment 1 intervention

Group B: Suturation groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Amount of bleeding

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

Time frame

From time of birth to the cessation of bleeding

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul Training and Research Hospital

Lead sponsor

Source ClinicalTrials.gov

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