ClinicalTrials.gg
RecruitingNCT06998641Updated Aug 17, 2026

EFFECTIVITY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS

An interventional study of Chitosan-covered-gauze application and Suturation in Effectiveness of Chitosan Covered Gauze to Stop Bleeding in Post-partum Tears and Comparison of the Effect of Chitosan Covered Gauze With Suturing in Terms of Hemostasis in Post-partum Haemorrhagic Tears, sponsored by Istanbul Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 48 Years. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Istanbul Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 48 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • 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

Keywords

  • chitosan-covered-gauze
  • post-partum lacerations
  • obstetrical tears
03

In context

Lead sponsor

Istanbul Training and Research Hospital is the lead sponsor of 66 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 48 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • Provision of written for participation in the study.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Failure to provide .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    chitosan-covered-gauze applied tears

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

    Procedure: Chitosan-covered-gauze application

  • Active comparator
    Suturation group

    Hemostasis of the tears is obtained by suturing

    Procedure: Suturation

Interventions

  • ProcedureChitosan-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

  • ProcedureSuturation

    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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Istanbul Training and Research Hospital Department of Obstetrics and Gynecology
    Istanbul, Turkey (Türkiye)
    Recruiting
    • Doruk C Katlan · Contactdcek2000@yahoo.com · +90 535 347 54 11
    • Nebahat Uzunay · Contactnebahatuzunay@gmail.com · + 90 505 260 94 36
    • Doruk C Katlan · Principal investigator
    • Nebahat Uzunay · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06998641
Lead sponsor
Istanbul Training and Research Hospital
Responsible party
Doruk Cevdi Katlan (Maternal Fetal Medicine Specialist, Istanbul Training and Research Hospital) — Principal investigator
First posted
May 31, 2025
Start date
Mar 1, 2025
Primary completion
Mar 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 17, 2026

Study contacts

Doruk C Katlan
Contact
dcek2000@yahoo.com
+90 535 347 54 11

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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