HAYMAN-1: Hayman's Haemostatic Suture to Treat Severe Post-partum Haemorrhage
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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.
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Outcome Measures
Primary Outcome Measures
- Fertility preservation [Within 24 hours after post-partum haemorrhage]
Number of cases in which it was not necessary to perform hysterectomy.
Secondary Outcome Measures
- Blood transfusions [Within 24 hours after post-partum haemorrhage]
Intraoperative transfusions (units).
- Subsequent pregnancies [120 months from the date of post-partum haemorrhage.]
Number of subsequent pregnancies (in case of successful management of Post-partum Haemorrhage)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Women that had major Post-partum Haemorrhage, resistant to pharmacologic therapy, treated with Hayman's Haemostatic Suture.
Exclusion Criteria:
- None.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Università degli Studi dell'Insubria
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HAYMAN-1