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Clinical Trials/NCT03442491
NCT03442491
Unknown
Not Applicable

Efficacy of Hayman's Haemostatic Suture for the Treatment of Severe Post-partum Haemorrhage Resistant to Pharmacologic Therapy

Università degli Studi dell'Insubria0 sites90 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Hemorrhage
Sponsor
Università degli Studi dell'Insubria
Enrollment
90
Primary Endpoint
Fertility preservation
Last Updated
4 years ago

Overview

Brief Summary

Post-partum haemorrhage continues to be a leading cause of maternal mortality and morbidity, accounting for more than 125 000 deaths per year across the world. Prompt diagnosis and effective action are the cornerstones of management and are crucial to prevent fatal maternal haemorrhage.

Considering that published data are extremely limited, the aim of our study will be to evaluate retrospectively the efficacy of Hayman's Haemostatic Suture for the treatment of resistant post-partum hemorrhage resistant to pharmacological therapy.

Detailed Description

Post-partum haemorrhage continues to be a leading cause of maternal mortality and morbidity, accounting for more than 125 000 deaths per year across the world. Prompt diagnosis and effective action are the cornerstones of management and are crucial to prevent fatal maternal haemorrhage. The Hayman suture offers the potential advantages that can be applied fast and easy, a key point in an emergency situation, and avoids having to perform a lower segment hysterotomy when post-partum haemorrhage follows a vaginal delivery, therefore minimising the trauma to the atonic bleeding uterus. Considering that published data are extremely limited, the aim of our study will be to evaluate retrospectively the efficacy of Hayman's Haemostatic Suture for the treatment of resistant post-partum hemorrhage resistant to pharmacological therapy.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
February 1, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Università degli Studi dell'Insubria
Responsible Party
Principal Investigator
Principal Investigator

Antonio Simone Laganà

Medical Doctor

Università degli Studi dell'Insubria

Eligibility Criteria

Inclusion Criteria

  • Women that had major Post-partum Haemorrhage, resistant to pharmacologic therapy, treated with Hayman's Haemostatic Suture.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Fertility preservation

Time Frame: Within 24 hours after post-partum haemorrhage

Number of cases in which it was not necessary to perform hysterectomy.

Secondary Outcomes

  • Subsequent pregnancies(120 months from the date of post-partum haemorrhage.)
  • Blood transfusions(Within 24 hours after post-partum haemorrhage)

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