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

• Conditions: Postpartum Hemorrhage
• Interventions: Procedure: Hayman's Haemostatic Suture

• Registration Number: NCT03442491
• Lead Sponsor: Università degli Studi dell'Insubria

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.

Study Timeline

• Study First Submitted: 2018-02-11
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-22
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-30
• Study Start: 2022-06-01
• Primary Completion: 2023-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hayman's Haemostatic Suture	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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