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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Procedure: Hayman's Haemostatic Suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women that had major Post-partum Haemorrhage, resistant to pharmacologic therapy, treated with Hayman's Haemostatic Suture. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hayman's Haemostatic Suture<br>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. | Procedure: Hayman's Haemostatic Suture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Hemorrhage, Hayman's Haemostatic Suture