Hayman’s Haemostatic Suture to Treat Severe Post-partum Haemorrhage

Overview

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.

Full Title of Study: “Efficacy of Hayman’s Haemostatic Suture for the Treatment of Severe Post-partum Haemorrhage Resistant to Pharmacologic Therapy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: February 1, 2019

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.

Interventions

  • Procedure: Hayman’s Haemostatic Suture
    • After the uterus is exteriorised, bimanual compression is applied to check whether this stopped the bleeding, before the suture is applied. A number 2 polyglactin suture on a straight needle is used to transfix the uterus from front to back, just above the reflection of the bladder, and is then tied above the fundus of the uterus, while an assistant applies bimanual compression.

Arms, Groups and Cohorts

  • Hayman’s Haemostatic Suture
    • Women that had major Post-partum Haemorrhage, defined as postpartum blood loss in excess of 2000 ml, resistant to pharmacologic treatment and that underwent Hayman’s Haemostatic Suture.

Clinical Trial Outcome Measures

Primary Measures

  • Fertility preservation
    • Time Frame: Within 24 hours after post-partum haemorrhage
    • Number of cases in which it was not necessary to perform hysterectomy.

Secondary Measures

  • Blood transfusions
    • Time Frame: Within 24 hours after post-partum haemorrhage
    • Intraoperative transfusions (units).
  • Subsequent pregnancies
    • Time Frame: 120 months from the date of post-partum haemorrhage.
    • Number of subsequent pregnancies (in case of successful management of Post-partum Haemorrhage)

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

  • None.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Università degli Studi dell’Insubria
  • Provider of Information About this Clinical Study
    • Principal Investigator: Antonio Simone Laganà, Medical Doctor – Università degli Studi dell’Insubria
  • Overall Contact(s)
    • Antonio Simone Laganà, M.D., 3296279579, antoniosimone.lagana@asst-settelaghi.it

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